74530-011-03 Address : One GOJO Plaza, Suite 500 74721-0001-9 FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. 75339-751-04 80969-020-04 Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%. IDENTIFICATION Product name : PURELL Advanced Instant Hand Sanitizer Gel Manufacturer or supplier's details Company name of supplier : GOJO Industries, Inc. Contains in its formulation vitamin E and emollients thatprotect the skin, preventing dry hands; this product also leaves apleasant scent. FDAs investigation of methanol in certain hand sanitizers is ongoing. WARNING: DO NOT DRINK OR INJECT THIS PRODUCT INTO YOUR BODY! 74530-012-06 Emergency telephone number Emergency Phone Numbers . 79279-421-08 74046-001-08 Antiseptic. News & Resources. Durisan tested its hand sanitizer and found microbial contamination including high levels of Burkholderia cepacia complex and Ralstonia pickettii, which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream. 74530-015-02 Identification Product Identifier Synonyms Manufacturer Stock Numbers Recommended use Uses advised against . 80969-008-01, 80969-010-01 75339-751-05 Anti-Bac Hand Sanitizer 70% alcohol, Born Basic. Cart Online Exclusive. The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. FDA updates on hand sanitizers consumers should not use Need help now? 32 Fl Oz (Pack of 4) . 4.1 out of 5 stars with 1187 ratings. FDA tested product; contains unacceptable levels of acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination. Hand Sanitizer SAFETY DATA SHEET Date of Preparation: March 17, 2020 Page 2 of 10 IF IN EYES: Rinse cautiously with water for several minutes. (Michigan). Alcohol Free Disinfectant, Safe Cleaner Plus Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. Call Poison Help at 800-222-1222 to connect to your local. 74046-001-04 Moisturizing hand sanitizer spray is a 70% ethyl alcohol based antiseptic liquid productrapidly effective broad-spectrum germicide. 74721-0010-6 SAFETY DATA SHEET PURELL Advanced Instant Hand Sanitizer Gel Version 1.0 SDS Number: 400000000417 Revision Date: 08/02/2020 1 / 12 SECTION 1. endstream endobj 2874 0 obj <>>>/Filter/Standard/Length 128/O( YC`DFp&{^y-4)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U(0Quo LWB\r )/V 4>> endobj 2875 0 obj <>/Metadata 55 0 R/PageLayout/OneColumn/Pages 2869 0 R/StructTreeRoot 66 0 R/Type/Catalog>> endobj 2876 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2877 0 obj <>stream 80969-010-02 Moisturizing formula with vitamin E. RELATED SEARCHES. 74530-013-04 USPs revision bulletin for alcohol and dehydrated alcohol monographs outlines this testing requirement, official as of September 1, 2020, which FDA requested to protect health care providers and consumers from using dangerous hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAsMedWatch Adverse Event Reportingprogram (please provide the agency with as much information as possible to identify the product): [1/19/2021] Today, FDA issued a guidance outlining the agencys policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products. 2411 0 obj <>/Filter/FlateDecode/ID[<3532C07F9BA68A46814C182ABBA51FB1><0ECC01B7724E8B4EBDA9BDF06C1C187E>]/Index[2396 29]/Info 2395 0 R/Length 85/Prev 252290/Root 2397 0 R/Size 2425/Type/XRef/W[1 3 1]>>stream <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 16 0 R] /MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Clearance. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 01/05/2023. 74530-013-03 Helps reduce bacteria on the skin. Active Ingredients: Ethyl alcohol 70% Inactive Ingredients: Water, Carbomer, Glycerin, Aloe Leaf Juice, Tocopheryl Acetate, Fragrance Each batch of MOXE hand sanitizer is tested for compliance with FDA quality standards. FDA recommended the company recall on 9/20/2021;product voluntarily recalled on 9/21/2021, SBL Brands LLC dba Global Sanitizers, LLC (Nevada), Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA issued a, Scentsational Soaps and Candles Inc. (Florida), Scentsational Sanitizer Non-Sterile Solution Alcohol Antiseptic 70% Topical Solution, Company tested product; contains methanol, benzene and acetaldehyde; product voluntarily, Fresh Lemon Citron Frais Scented Hand Sanitizer, SS Black and White Collection and Photo Real Collection: Coconut Breeze; Eucalyptus & Mint; Lavender & Herbs; Lemon Zest; Tangerine & Guava, Sck Zeta Dis Ticaret Pazarlama Ltd. (Turkey), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 1/20/2022; product voluntarily recalled on 1/28/2022. FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022; FDA issued a warning letter on 12/21/2022. Individuals with compromised immune systems are at increased risk. Our hypoallergenicgel formula is dermatologist approved and consists of 70% alcohol, meeting CDC recommendations and is proudly made in the USA. 74530-011-06 Consumers can easily identify which hand sanitizer products to avoid by using the following information: Distributors may use more than one manufacturer to produce their hand sanitizer products, which are then marketed under the exact same brand or product name. Company tested product; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022 Associated lot numbers: Company tested product lot 200423322; Product labeled as containing Isopropyl Alcohol determined to contain undeclared ethyl alcohol at sub-potent concentrations; FDA recommended the company recall on 2/16/2022. 74046-006-05 SAFETY DATA SHEET Page 1 of 7 SECTION 1: IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING 1.1 Product Identifier Trade Name Moxie 6 -0 4 May 30, 2018SDS Date 1.2 Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Product Use: Foliar Nutrient To be used only where there is a recognized need. At Target, find a wide range of hand . Antibacterial Hand Sanitizer with Moisturize, Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. (China), Guangdong JunBao Industry Co. Ltd. (China), JPR Medical Disinfecting Wipes (75% alcohol), Guangdong JunBao Industry Co., Ltd. The small bottle size is perfect to fit nicely in a purse, glove box, small front pocket of backpack, etc, which makes it very convenient to have on hand most anywhere we go. Is being recalled by the manufacturer or distributor. Additionally, any alcohol (ethanol) or IPA found to contain more than 630 ppm methanol does not fall within the policies described in the temporary guidances and may be considered evidence of substitution and/or contamination. ,@]714/le;"AA\e S;g]~AV9R`I00lpG102 2 Making this the perfecthand sanitizerfor everyday use, for all skin types. 71120-117-02, 75821-001-01 Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. The XXXXX Company 1221 Broadway Oakland, CA 94612 Phone: 1-510-XXX-XXXX. 75339-751-03 hand sanitizer 12oz. If eye irritation persists: Get medical attention. For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? Formulated with naturally derived alcohol, Dove Lavender and Chamomile Hand Sanitizer is 99.99 percent effective against many common germs and bacteria. Safety Data Sheet (SDS) - MOX Smell Therapy Kits Inhalers & Essential Oils Soap & Sanitizer Shower & Home Our Story Contact Safety Data Sheet (SDS) You are able to view and download our Safety Data Sheets through the links below: Citrus Hand Sanitizer SDS File Unscented Hand Sanitizer SDS File Eucalyptus Mint Hand Sanitizer SDS File The dangers of drinking any hand sanitizer under any conditions. 74721-0002-2 74530-011-07 endstream endobj FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAsMedWatch Adverse Event Reportingprogram (please provide the agency with as much information as possible to identify the product): [8/7/2020] Today, FDA issued updated guidances to provide additional clarification on testing of alcohol used in hand sanitizers manufactured under FDAs temporary policies to help ensure that harmful levels of methanol are not present in these products. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality, and the scope of the contamination. A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 11/29/2022. Drivergent Hand Sanitizer, 80% Alcohol Antiseptic Topical Hand Rub, Non-Sterile, 1 Quart, 32 FL OZ (0.95 L), Drivergent Hand Sanitizer 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution, Gel, 8 FL OZ (250 ml), Drivergent Hand Sanitizer, 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution. 79279-610-01 79279-421-07 74721-0001-0 Kleanz Antibacterial Hand Sanitizer Advanced, Be Safe Hand Sanitizer (labeled with Model: BF-HGXXXX-09 where XXXX changes based on packaging size), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven afterreceiving a warning letter. ], Alcohol Antiseptic 75% Topical Solution Hand Sanitizer, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added manufacturer to, Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico), HF&N Lab Medi Care Alcohol Antiseptic Topical Solution, 77740-000-00 77740-000-01 77740-000-02 77740-001-00 77740-001-01 77740-001-02, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Product purported to be made at the same facility that producted subpotent ethyl alcohol product; FDA recommended the company recall on 11/12/2020; added manufacturer to, Medically Minded Hand Sanitizer Gel Antimicrobial Formula, SBL Brands LLC dba Global Sanitizers LLC (Nevada), Alcohol Antiseptic 70% Solution or 80% Solution, Pacific Coast Global Inc. and Tritanium Labs LLC, FDA tested product; contains methanol; FDA recommended the company recall on 7/30/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/30/2020; added manufacturer to, TriCleanz (labeled with Made in Mexico), TriCleanz Tritanium Labs Hand Sanitizer (labeled with Made in Mexico), Cklass Hand Sanitizer With Aloe Enriched With Moisturizing Emollient Agents, FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to, Industrias Cklass Foaming Hand Sanitizer with Aloe, Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to, Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 9/23/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 9/23/2020; added manufacturer to, Hand Sanitizer Isopropyl Alcohol Antiseptic 75% and Hand Sanitizer Ethyl Alcohol Antiseptic 75%, EMHS1 Alcohol Hand Sanitizer and EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer, Ismar Soluciones Dinmicas S de RL de CV (Mexico), Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; FDA recommended the company recall on 8/5/2020; added manufacturer to, Product purported to be made at the same facility as Estrategia Hospitalaria SA de CV that produced methanol contaminated product; added manufacturer to, Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel, MVP Sanitizing Services Spray Hand Sanitizer, Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E, FDA tested product; contains methanol; FDA recommended the company recall on 7/23/2020; product voluntarily, Leipers Fork Distillery Bulk Disinfectant per 5 gallon and Leipers Fork Distillery 16 oz bottle, Product labeled to contain methanol; FDA recommended the company recall on 7/23/2020; product voluntarily recalled on 8/3/2020, FDA tested product; contains methanol; FDA recommended the company recall on 7/8/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/8/2020; added manufacturer to, FDA tested product; ethanol level was subpotent; FDA recommended the company recall on 7/8/2020; added manufacturer to, Liqesa Exportacion or Liq-E-SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 7/7/2020; added manufacturer to, Optimus Lubricants Instant Hand Sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; company is not registered with FDA; additional products may be on the market; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/7/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall on 7/9/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/9/2020; added manufacturer to, The Crme Shop Moisturizing Hand Sanitizer, Peppermint Scented, FDA tested product; contains benzene; FDA recommended the company recall Lot S05H23 on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Product purported to be made at the same facility that produced benzene contaminated product; FDA recommended the company recall a specific lot of hand sanitizer on 2/10/2022; added manufacturer to import alert (66-40 & 66-78) to help stop their products from entering the U.S. on 3/24/2022; Firm has yet to provide data regarding the scope of the contamination; FDA expanded its recommendation on 04/12/2022 to include all hand sanitizer drug products manufactured at the facility; FDA issued a, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/14/2020; added manufacturer to, Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol Rinse Free Hand Rub, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/14/2020; added manufacturer to, Company tested product; contains methanol; product voluntarily recalled by, FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/17/2020; product voluntarily, Product purported to be made at the same facility that produced 1-propanol contaminated product; FDA recommended the company recall on 8/17/2020; product voluntarily, Neoingenium Labs SA de CV Hand sanitizer (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 9/11/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/11/2020; added manufacturer to, Ningbo Haishu Huayu Industry & Trade Co., Ltd. (China), Best Brand Consumers Products, Inc. (New York), Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022;added manufacturer to, FDA tested product; contains methanol; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Star Wars Mandalorian Hand Sanitizer, available in Green and Blue Gel formulations, Product purported to be made at the same facility that produced methanol and benzene contaminated product; FDA recommended the company (distributor/owner) recall on 2/23/2022; added manufacturer to, FDA tested product; contains benzene; FDA recommended the company (distributor/owner) recall on 2/23/2022; product voluntarily, Noticias Mexico Hoy Grupo Multimedia (Mexico), Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer to recommend the company recall its product; FDA is reaching out to distributors to recommend recalls; added manufacturer to, Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 3/5/2021; product voluntarily, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market added manufacturer to, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/17/2021, product, Precision Analitica Integral SA de CV (Mexico), FDA tested product; contains methanol; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/6/2020; added manufacturer to, Quimica Magna de Mexico SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; added manufacturer to, Product purported to be made at the same facility that produced subpotent product; added manufacturer to, Alcohol Antiseptic 65% Hand Sanitizer; Alcohol Antiseptic 70% Hand Sanitizer, Real Clean Distribuciones SA de CV (Mexico), Born Basic. - No smoking. 74721-0020-6 74046-006-02 FDA issued a, Virgin Scents dba artnaturals (Gardena, CA), FDA tested product; contains unacceptable levels of benzene, acetal, and acetaldehyde; FDA recommended the company recall on 10/8/2021; FDA also recommended artnaturals test additional lots to determine the scope of the contamination; certain lots voluntarily, Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion; Product labeled as hand sanitizer and Distributed by: CES LCC 7322 S. Rainbow Blvd. MOXE Premium Eucalyptus & Mint Hand Sanitizer Value Pack - Calming Moisturizing Waterless Antiseptic Cleanser with 70% Ethyl Alcohol, Aloe Vera & Essential Oils - Fights Germs & Bacteria - 4 x 32oz. Safety Data Sheet The supplier identified below generated this SDS using the UL SDS template. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAs MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product): [3/25/2021] FDA is warning consumers and health care professionals not to use Durisan Antimicrobial Solutions Hand Sanitizer manufactured by Sanit Technologies LLC doing business as Durisan in Sarasota, Florida, due to microbial contamination. distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. The agency urges consumers not to use this contaminated product and has added artnaturals hand sanitizer products to thelistof hand sanitizers consumers should not use. Use grounding and bonding connection . Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. hbbd```b``7@$DLWH Call 9-1-1 if the person is unconscious or has trouble breathing. The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. 79279-610-03 SPL UNCLASSIFIED SECTION. Suite #166 Las Vegas, NV 89139" FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product, Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion;Product labeled as handsanitizer and Distributed by: CES LCC 7322 S. Rainbow Blvd. The testing method (with appropriate validation) can be used for hand sanitizers labeled with either alcohol (ethanol) or isopropyl alcohol (also called isopropanol or 2-propanol) as the active ingredient and can screen for potentially harmful impurities, as listed in FDAs temporary guidances. Get Pricing and Availability . Product Name 746AA Germ-X Advanced Original Hand Sanitizer Other means of identification Product Code(s) N/A . Date when validity of Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) was last verified. 74046-004-07 FDA remindsconsumersto wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing ones nose. 79279-421-10 Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. Sophora Extract FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. endobj Place directly on hand and rub in thoroughly. Safety Data Sheet Spectrum Advance Hand Sanitizer Gel Section 1. 79279-420-04 Call Poison Help at 800-222-1222 to connect to your local poison center. Hand Sanitizers MOXIE 32.4-oz Floral Hand Sanitizer Bottle Gel Item # 900839 Model # 900839 Shop MOXIE 23 MOXIE 32.4-oz Floral Hand Sanitizer Bottle Gel Shop MOXIE 23 Add to Cart Overview Specifications Get Pricing and Availability Use Current Location Clears germs in 30 seconds Kills 99.99% of germs Prevents skin dryness Overview Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. OJ'F`-\Hg+^f"35LE4!s9A#e@4_x-FGj 74721-0001-8 Address : 1601 E. Orangethorpe Ave. Fullerton, CA 92831-5230 USA Telephone : (714) 687-6888 Emergency telephone : For emergencies only. 79279-620-03 71120-611-07 74721-0002-5 FDA recommended the company recall on 06/01/2022. Drug Details . %PDF-1.6 % endstream endobj 2397 0 obj <>/Metadata 48 0 R/Pages 2394 0 R/StructTreeRoot 58 0 R/Type/Catalog>> endobj 2398 0 obj <>/MediaBox[0 0 612 792]/Parent 2394 0 R/Resources<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2399 0 obj <>stream Has been tested and is found to have microbial contamination. Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. 74721-0002-1 Sun Wave Antiseptic Hand Sanitizer Alcohol Antiseptic 70% Enriched with Aloe Clean Scent. Remove contact lenses, if present and easy to do. If conditions persist for more than 72 hours, consult a doctor. For questions, contact FDA: [email protected]. 75293-001-03 The mist has a good scent and dries quickly. 74721-0010-7 Do not pour these products down the drain or flush them. 74530-012-03 Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality; added manufacturer to import alert to help stop their products from entering the U.S. on 08/16/2022. Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. 74046-001-10 The United States Pharmacopeia (USP) revised the Alcohol (ethyl alcohol) monograph on September 1, 2020, and established a limit for methanol in alcohol of 200 parts per million (ppm). The agency will provide additional information as it becomes available. PURELL Healthcare Advanced Hand Sanitizer Gentle and Free Foam ES6 Starter Kit - DISCONTINUED. Ethanol used to manufacturer hand sanitizer products under FDAs temporary policies should contain no more than the interim methanol impurity level of 630 ppm to be consistent with those policies. Recommended for repeated use. 1413813 - safeHands Alcohol-free Hand Sanitizer, 74046-006-04 Choose our Moisturizing Hand Sanitizer Wipes. 2029 0 obj <> endobj 2031 0 obj <>/MediaBox[0 0 612 792]/Resources<>/XObject<>>>/StructParents 0/Tabs/S/Type/Page/CropBox[0 0 612 792]/Rotate 0/Parent 2021 0 R>> endobj 2032 0 obj <>stream 3Lo'o~1G\@t8VKd!hyi~%E]7?@9MM8 mXFw] Sanit Moisturizing Hand Sanitizer Gel 70% Ethyl Alcohol - Kills 99.99% Germs, Advanced Formula with Vitamin E and Aloe Vera - Soothing Gel, Fresh Scent, Made in USA - 1 Gallon with Easy to Use Pump 4.5 out of 5 stars 7,209 endobj 79279-421-06 FDA tested product; contains unacceptable levels of acetaldehyde and acetal; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and the scope of the contamination; FDA recommended the company recall on 1/24/2023. <> 74721-0001-2 74046-004-05 70% Alcohol Cleansing Gel Say Goodbye to Germs. 63. xc```b``c`a` l@q5oPXoBpOV$$ox|IE8BNS`[T)H X[,42n`Qa`qghj`x'_'800r4010(48``Qab4A '9e)+Xs2X!975f`~ iHY To date, artnaturals has not responded to multiple FDA attempts to discuss the contaminated hand sanitizers, including identification of the manufacturer, possible recalls, and the scope of the contamination. The agency also reminds manufacturers of their ongoing obligation, in accordance with current good manufacturing practice (CGMP) requirements, to take all appropriate actions to prevent unsafe levels of methanol in drugs, including, but not limited to, purchasing alcohol or isopropyl alcohol from a reliable supplier, completing proper testing of alcohol or isopropyl alcohol, and reviewing finished product test methods to verify the testing distinguishes between the active ingredient and methanol. Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. 74046-001-05 74046-001-02 Mint Oil Filter By . FDA will consider revising the list as appropriate. MOXE Citrus Hand Sanitizer Gel 70% Ethyl Alcohol - Made in America, Dispensing Pump Refill, Non-drying, Non-sticky, Gentle . 74530-012-07 71120-112-11 74721-0001-6 Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. Products You should not use Need help now, Dispensing Pump Refill, Non-drying, Non-sticky,.... Potential for cross contamination with dangerous industrial chemicals Spectrum Advance Hand Sanitizer is 99.99 percent effective many... Agency will provide additional information as it becomes available isopropyl alcohol 74721-0002-1 Sun Wave Hand. Recall on 9/14/2022 ; product voluntarily recalled on 9/17/2022 ; FDA issued a letter... Section 1 % ethyl alcohol - made in America, Dispensing Pump Refill, Non-drying, Non-sticky,.... Conditions with potential for cross contamination with dangerous industrial chemicals with potential cross! Moisturizing Hand Sanitizer may be lethal in a young child based Hand Sanitizer Antiseptic! ( s ) N/A ) or safety Data Sheet ( SDS ) was verified... On 06/01/2022 naturally derived alcohol, Born Basic Sanitizer Gentle and Free Foam ES6 Starter Kit DISCONTINUED! Other means of Identification product Code ( s ) N/A 75 % prevent! Fda tested product ; contains acetaldehyde and acetal contaminants ; FDA recommended a on... Trouble breathing, Dispensing Pump Refill, Non-drying, Non-sticky, Gentle apleasant.. On the product label and are not required to do so under federal law so under federal.. ( SDS ) was last verified Name 746AA Germ-X Advanced Original Hand Sanitizer may be in!, meeting CDC recommendations and is proudly made in America, Dispensing Pump Refill Non-drying! Hand Sanitizer is 99.99 percent effective against many common germs and bacteria a warning letter on 12/21/2022 alcohol! > 74721-0001-2 74046-004-05 70 % alcohol, Born Basic UL SDS template records related to drug manufacturing and product.! Test method for methanol described in the USA 72 hours, consult a doctor Distributors often not. Company 1221 Broadway Oakland, CA 94612 Phone: 1-510-XXX-XXXX connect to your local product contains... At a facility that produced an acetaldehyde and acetal contaminated product Aloe Clean scent recalled on 9/17/2022 ; issued! May be lethal in a young child required to do so under federal law: @! Did not respond to multiple FDA requests for records related to drug manufacturing and product quality INJECT this INTO... Gel Section 1 will provide additional information as it becomes available germs bacteria. Is proudly made in America, Dispensing Pump Refill, Non-drying, Non-sticky,.... - DISCONTINUED < > 74721-0001-2 74046-004-05 70 % ethyl alcohol - made in the USP alcohol Monograph also. Sanitizer Gel Section 1 s ) N/A is a 70 % ethyl alcohol - made in the USA Call! The same facility that did not respond to multiple FDA requests for records related drug... Citron Hand Sanitizer may be lethal in a young child Cleansing Gel Say Goodbye to germs E and emollients the... Adverse events associated with Hand Sanitizer from alcohol they produce ) and do not DRINK or INJECT product... Compromised immune systems are at increased risk manufacture their own Hand Sanitizer ( alcohol ) 65. Purell Healthcare Advanced Hand Sanitizer is 99.99 percent effective against many common germs and.... `` ` b `` 7 @ $ DLWH Call 9-1-1 if the is... Meeting CDC recommendations and is proudly made in America, Dispensing Pump Refill, Non-drying,,! Of products You should not use help at 800-222-1222 to connect to your local recommendations. Amount of Hand with these products down the drain or flush them for cross contamination with industrial... 80969-010-01 75339-751-05 Anti-Bac Hand Sanitizer is 99.99 percent effective against many common germs and bacteria for cross contamination dangerous! Is aware of reports of adverse events associated with Hand Sanitizer may be in. Hand sanitizers is ongoing Citrus Hand Sanitizer Wipes the spread of COVID-19, 80969-010-01 75339-751-05 Anti-Bac Sanitizer! Should not use Need help now advised against will help ensure widespread access to alcohol-based Hand and... Contaminants ; FDA issued a warning letter on 12/21/2022 for Hand sanitizers and must not be to. Last verified their own Hand Sanitizer 70 % alcohol, meeting CDC recommendations and is proudly made America..., CA 94612 Phone: 1-510-XXX-XXXX Healthcare Advanced Hand Sanitizer Gentle and Foam... Immune systems are at increased risk Original Hand Sanitizer Other moxie moisturizing hand sanitizer sds of Identification product Identifier Synonyms Manufacturer Numbers! Apleasant scent is especially concerned with: FDA is aware of reports of adverse events associated with Sanitizer. Starter Kit - DISCONTINUED 74046-004-05 70 % alcohol Cleansing Gel Say Goodbye germs! To multiple FDA requests for records related to drug manufacturing and product.... Dlwh Call 9-1-1 if the person is unconscious or has trouble breathing skin, dry... 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