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). 74530-013-03 [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished 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): [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. hbbd```b``z"dd&{0 Lnf_etH2V!8_RDg1+@ $/ 74046-001-17 79279-520-06 Use grounding and bonding connection . FDA recommended the company recall on 9/14/2022; product voluntarily recalled lot 1166A on 9/17/2022; FDA issued a warning letter on 12/21/2022. 74721-0002-8 Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. 71120-611-07 Moisturizing hand sanitizer spray is a 70% ethyl alcohol based antiseptic liquid productrapidly effective broad-spectrum germicide. 71120-117-02, 75821-001-01 Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. endobj Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Moisturizing Gel Hand Sanitizer Moisturizing Gel and Waterless Hand Sanitizer Our antimicrobial and waterless hand sanitizer is formulated with 62% ethyl alcohol (by weight) as well as emollients and moisturizers to help improve skin health with continued use. by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. 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. 74530-015-03 <>/Metadata 757 0 R/ViewerPreferences 758 0 R>> Artnaturals Hand Sanitizer Infused with Jojoba Oil, Germ Free Anti-Bacterial Instant Hand Sanitizer, Apollo Instant Hand Sanitizer Anti Bacterial, Health & Wellness Essentials Hand Sanitizer Wash-Free, New Sanicol Advanced Antibacterial Hand Sanitizer, National Travel Products, Inc (New Jersey), 74530-015-01 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. Before sharing sensitive information, make sure you're on a federal government site. 32 Fl Oz (Pack of 4) . Zep Hand Sanitizers. Cultivation Republic (Clearwater, Florida). 75339-751-04 74721-0001-7 Alcohol Free Disinfectant, Safe Cleaner Plus US Phone: 866-748-9990 Fax: 413-513-1330 sales@safehands.com 866-748-9990. 80969-010-06 SAFETY DATA SHEET 1. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. PROVON Moisturizing Hand & Body Lotion. Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. 71120-611-08 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 71120-112-11 Product Number: 234AC Product Name: Germ-X Hand Sanitizer (w/o IPA) Issuing Date: January 16, 2015 Revision Date: None Revision Number: 0 Safety Data Sheet for Health and Beauty Products Page 1 / 10 1. Supplier Address Vi-Jon Inc. 8800 Page Avenue Saint Louis MO 63114 US Supplier Phone Number Phone: 314 -427 1000 (M-F 8am-4pm CST) Fax:3144271010 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 Keep out of reach of children. FDAs investigation of methanol in certain hand sanitizers is ongoing. GENTLE, MOISTURIZING, & NON-DRYING - It applies smoothly and dries quickly. x\mSc3t:;w@q_%[vLIGM9?_LbQ.1vOUh*{[ObRO/nP):=(?j>F( 79279-610-02 75339-751-03 Do not pour these products down the drain or flush them. 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. Page 1 / 10 . Clorox Hand Sanitizers. Individuals with compromised immune systems are at increased risk. Company did not respond adequately to multiple FDA requests for records and other information related to drug manufacturing, product quality and questions regarding possibility of methanol contamination which cannot be ruled out; the firm announced a voluntary recall on 10/18/2022. 74721-0020-0 Consumers who have products on this list of hand sanitizers should immediately stop using the product and dispose of it, ideally in a hazardous waste container. 74530-011-07 Hand Sanitizer Revision Date 02-Apr-2020 7. Use Current Location. 74721-0020-1 74530-011-03 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. Has been tested and is found to have microbial contamination. 71120-612-06 Blaster Hand Sanitizers. HANDLING AND STORAGE Precautions for safe handling Handling Handle in accordance with good industrial hygiene and safety practice. FDA recommended the company recall on 06/01/2022. 79279-620-05. 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. (Michigan). 74046-001-12 74046-001-16 79279-521-03 Moxie Paper Towels. Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. 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. Leaving nothing behind, but the invigorating smell of citrus & moisturized hands. endstream endobj #}7G8~m$03t:F_0(FQ\xeEl[8(8`O#u^Oq>>f`ra$+Bd'E/?|] ztap. Our hypoallergenicgel formula is dermatologist approved and consists of 70% alcohol, meeting CDC recommendations and is proudly made in the USA. Choose our Moisturizing Hand Sanitizer Wipes. Online Exclusive. While USP has not yet updated the Isopropyl Alcohol Monograph to include a specific methanol limit, FDA may consider the 200 ppm methanol limit for ethanol to also be suitable for isopropyl alcohol. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. English Spanish. Date of first issue: 06/19/2019 SECTION 1. (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 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. Filter By . SPL UNCLASSIFIED SECTION. x\[s6~agq't76}`l]6{HI73hpp xW*\\._.Go,SN=yy]#2g8.H 2/^+2;xe#rGgmqIo-Xc682E.o'}}Y>x!. 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. Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. 74530-011-05 75821-001-03 For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? SAFETY DATA SHEET Scott Moisturizing Foam Hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS Number: . Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. 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. FDA recommended the company recall all drug products on 12/12/2022. Moxie Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L G Sourcing, Inc.. Drug facts, warnings, and ingredients follow. PROVON 3~in~1 Wash Cream. 74046-001-14 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. Dongguan Mingyi Medical Products, Co., Ltd. FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. 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. 74530-012-04 If soap and water are not readily available, theCenters for Disease Control and Prevention(CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol). Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. 75821-002-03. Remove contact lenses, if present and easy to do. Moisturizing Hand Sanitizer $7.95. 2028 0 obj <> endobj 79279-620-02 74046-001-07 It rubs in clean without any of that goopy after feel. Consumer and health care professional safety is a top priority for FDA, and an important part of FDAs mission is to protect the public from harm, especially as we seek to help increase hand sanitizer supply. FDA has updated our guidances to provide clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. And it doesn't dry your skin. 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. 74530-013-06 74046-001-05 79279-420-05 74721-0002-9, 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 7/12/2022, Safe Cleaner K 74530-015-04 74046-001-04 Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. 74046-001-09 The .gov means its official.Federal government websites often end in .gov or .mil. Dove Beauty Shea Butter & Warm Vanilla Moisturizing Hand Sanitizer Wipes - 20ct. Suite #166 Las Vegas, NV 89139";FDArecommended the company recallon11/3/2021;product voluntarilyrecalledon11/4/2021, Medically Minded Antimicrobial Hand Sanitizer Gel with Vitamin E and Moisturizer, SBL Brands LLC dba Global Sanitizers LLC(Nevada), FDA tested product; contains methanol; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Anitmicrobial Formula, Products possibly made at the same facility that produced methanol contaminated product; FDA has been unable to determine the manufacturer to recommend a recall; FDA recommended the distributor recall on 5/6/2021; product voluntarily, Medically Minded Hand Sanitizer Gel Antimicrobial Formula with Vitamin E and Moisturizer, Product labeled to contain methanol; FDA recommended the company recall on 8/7/2020; product voluntarily recalled on 8/14/2020, WelburnGlobal SociedadAnonima(Guatemala), Product manufactured at a facility that did not respond to multiple FDA requests for recordsrelated to drug manufacturing and product qualityeven after receiving a warning letter. 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