74721-0002-3 75339-751-02 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. 79279-521-02 1413813 - safeHands Alcohol-free Hand Sanitizer, FDA will consider revising the list as appropriate. FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; FDA issued a warning letter on 01/30/2023. #}7G8~m$03t:F_0(FQ\xeEl[8(8`O#u^Oq>>f`ra$+Bd'E/?|] ztap. 80969-010-02 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested. 79279-520-09 Notice to manufacturers and distributors: If you believe your products are no longer within the labeled expiry period, are no longer in distribution, or you otherwise have information that your products no longer warrant inclusion on this list, you should provide your reasoning and supporting information for FDAs consideration toHSDoNotUseListInquiries@fda.hhs.gov. 74530-015-03 74530-011-08, 74530-013-01 74721-0002-8 Filter By . Add to Bag previous product image next product image. Active Ingredient(s) Alcohol 70% v/v. Details of the supplier of the safety data sheet Supplier Name Vi-Jon Inc. 74046-006-07 Call 9-1-1 if the person is unconscious or has trouble breathing. 74721-0010-8 Additionally, any repackers who distribute hand sanitizers and other ethanol or isopropyl alcohol-based drugs, should know who they are purchasing from and conduct the necessary due diligence to ensure the drugs they sell are safe for consumers. Place directly on hand and rub in thoroughly. 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 74046-001-04 Hand Sanitizer Industrial and Hospital Grade, FDA tested product; ethyl alcohol level was subpotent; added to, Guangzhou Youxing Cosmetics Co. Ltd.(China), V&W Advance Hand Sanitizer Refreshing Gel, Guangzhou Youxing Cosmetics Co. Ltd. (China), V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc. 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. Address : One GOJO Plaza, Suite 500 [8/12/2020] FDA is warning consumers and health care professionals about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. [7/31/2020] FDA continues to find issues with certain hand sanitizer products. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. endstream endobj startxref [10/4/2021]FDA has tested certain artnaturals scent free hand sanitizer labeled with DIST. FDA updates on hand sanitizers consumers should not use Need help now? (Michigan). -. 80969-007-01 The agency continues to add certain hand sanitizers to theimport alertto stop these products from legally entering the U.S. market and has issued warning letters to companies that violate federal law. 79279-521-04 Topical Solution. 74721-0010-6 79279-620-03 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. Moisturizing formula with vitamin E. RELATED SEARCHES. Use personal protection equipment. 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. Methanol is not an acceptableingredient for hand sanitizers and must not be used due to its toxic effects. Safety Data Sheet Spectrum Advance Hand Sanitizer Gel Section 1. 74721-0001-7 Keep out of reach of children. . Germ-X Aloe Moisturizing Hand Sanitizer has plenty of germ-fighting power and contains 62 percent sanitizing alcohol. Water (aqua), glycerin, carbomer, triethanolamine, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benoate. 32 Fl Oz (Pack of 4) . 74530-015-04 (China), Be Cleaner Be Healthier 75% Alcohol Wipes, One Drop Care Alcohol Disinfectant Wet Wipes, 75339-751-01 Alcohol Free Disinfectant, Safe Cleaner Plus 79279-421-10 <> . Do not pour these products down the drain or flush them. 74721-0010-4 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 Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. The site is secure. HAND SANITIZER Isopropyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; contains benzene; FDA recommended the company recall Lot 200324 (expiration date unknown) on 03/30/2022, Product labeled to contain methanol; FDA recommended the company recall on 11/18/2021. 79279-610-05 79279-521-03 The agency will provide additional information as it becomes available. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. 74046-006-04 stream FDA is not aware of any adverse events related to Durisans hand sanitizer products. FDA recommended the company recall on 06/01/2022. 75821-001-03 Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. 74721-0001-8 79279-521-05 74721-0010-9 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. 74530-013-03 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. Moxie Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L G Sourcing, Inc.. Drug facts, warnings, and ingredients follow. <>/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>> [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. Is purportedly made at the same facility as products that have been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel 79279-610-02 79279-420-04 2030 0 obj <>stream 4.1 out of 5 stars with 1187 ratings. Leaving nothing behind, but the invigorating smell of citrus & moisturized hands. Identification Product Identifier Synonyms Manufacturer Stock Numbers Recommended use Uses advised against . 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. Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. Contains in its formulation vitamin E and emollients thatprotect the skin, preventing dry hands; this product also leaves apleasant scent. Infection can occur with use of the contaminated hand sanitizer by consumers or by health care professionals who may also transmit the contaminating bacteria to patients. HCZsu^KLhcKZl*Dj9Y;aBJp~'{a#i.UB |wPnYu$&}W2F'. x\mSc3t:;w@q_%[vLIGM9?_LbQ.1vOUh*{[ObRO/nP):=(?j>F( Consumers who have products on thelist of hand sanitizerswith potential contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. 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. 74046-004-03 74530-013-07 Item #889085. Product purported to be made at the same facility that produced product containing acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. Call Poison Help at 800-222-1222 to connect to your local. Product Description 74530-011-02 Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. Guangzhou Minghui Cosmetics Co. Ltd. (China), Product purported to be made at the same facility that produced subpotent ethyl alcohol product;added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued awarning letteron 07/06/2021; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021, Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. 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 5/16/2022; FDA issued a warning letter on 07/20/2022. Use Current Location. At Target, find a wide range of hand . 74046-004-08 They're 99.9% effective against many germs and made with 100% plant-based fibres, which are developed to break down when home composted and meet ASTM D6868 standards for compostability. Clorox Hand Sanitizers. 1187. . J0b?b `6 Y"4pD9_0012p30 /y Grapefruit Extract, 74721-0010-1 Individuals with compromised immune systems are at increased risk. hbbd```b``7@$DLWH 74721-0020-7 2028 0 obj <> endobj Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. 74046-001-18 The policy outlined in this guidance applies to all pharmaceutical alcohol used as an active or inactive ingredient in a drug, including hand sanitizer under the FDAs temporary policies for preparing alcohol-based hand sanitizer during the COVID-19 pandemic. Not an acceptableingredient for hand sanitizers approved by FDA a # i.UB |wPnYu $ & W2F! Advised against s ) Alcohol 70 % v/v its formulation vitamin E and emollients thatprotect skin. Dry hands ; this product also leaves apleasant scent with compromised immune systems are at increased risk percent Alcohol. To import alert to stop these products down the drain or flush them Alcohol-based sanitizers! 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