Date of first issue: 06/19/2019 SECTION 1. endstream endobj startxref Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. 74721-0020-5 The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death. GENTLE, MOISTURIZING, & NON-DRYING - It applies smoothly and dries quickly. -. <>/Metadata 757 0 R/ViewerPreferences 758 0 R>> Use Current Location. 75821-001-04 . 80969-040-04, PFA Stronghold Hand Sanitizer 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. English Spanish . 74721-0001-8 Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. Model #20-21838. 74046-001-09 74530-011-04 2396 0 obj <> endobj 74530-015-06, 74530-011-01 Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. 74046-001-10 %PDF-1.5 % Moisturizing formula with vitamin E. RELATED SEARCHES. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. Remove contact lenses, if present and easy to do. 71120-117-02, 75821-001-01 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. 75293-001-04 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. Animal studies show acetaldehyde may cause cancer in humans and may cause serious illness or death. 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. Softsoap. (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 32 Fl Oz (Pack of 4) . 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 09/09/2022. Avoid breathing vapors or mists. 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. A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. 74046-006-02 71120-611-08 An official website of the United States government, : . 74046-004-04 71120-612-07 FDA recommended the company recall all drug products on 12/12/2022. 71120-112-06 Emergency telephone number Emergency Phone Numbers . 74046-006-10. % 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. 80969-020-04 79279-610-05 74046-006-05 Drug Facts. Details of the supplier of the safety data sheet Supplier Identification Address Telephone E-mail Emergency telephone number Company Emergency Phone . 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. Clorox Hand Sanitizers. #}7G8~m$03t:F_0(FQ\xeEl[8(8`O#u^Oq>>f`ra$+Bd'E/?|] ztap. Cosmeticos Ltda, (Brazil), Biotipo Pharma Medical Antibacterial Antiseptic Cleanser Disinfectant, 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 10/18/2022, Reborncare Hand Sanitizer (100mL, 250mL, 500mL). 06/15/2020. 71120-112-10 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. 74046-001-04 hbbd```b``z"dd&{0 Lnf_etH2V!8_RDg1+@ $/ Moxie Moisturizing Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE; Type 0: Not a Combination Product. 74530-012-06 74721-0001-6 74721-0002-3 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). hand sanitizer 12oz. [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. 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. 74046-004-02 And it doesn't dry your skin. 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. 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. 79279-520-09 74721-0002-7 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). Place directly on hand and rub in thoroughly. FDA issued a, Yara Elena de La Garza Perez Nieto (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 7/10/2020; added manufacturer to, Product labeled to be edible alcohol; added manufacturer to. 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. Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). 74721-0001-5 Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. Helps reduce bacteria on the skin. 74046-004-09 News & Resources. 79279-521-04 The agency urges consumers not to use these 1-propanol-contaminated products and has expanded its do-not-use list of hand sanitizers at www.fda.gov/unsafehandsanitizers to include hand sanitizers that are or may be contaminated with 1-propanol, in addition to other hand sanitizers the agency is urging consumers not to use. Uses. Use of this contaminated hand sanitizer by health care professionals who tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization or extend an existing hospitalization. 1187. . 74046-006-06 %PDF-1.6 % Blog. 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 09/27/2022; product voluntarily recalled on 9/27/2022. IDENTIFICATION Product identifier Mixture identification: Trade name: Hand Sanitizer 80% Alcohol Other means of identification: Trade code: SN3000001011C Recommended use of the chemical and restrictions on use: Our hypoallergenicgel formula is dermatologist approved and consists of 70% alcohol, meeting CDC recommendations and is proudly made in the USA. Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. [10/28/2021] FDA is alerting health care professionals and consumers of artnaturals voluntaryrecall of limited batches of 8 oz bottles of Scent Free Hand Sanitizer. 79279-610-04 FDA recommended the company recall on 06/01/2022. Amazon.com : 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 : Health & Household Health & Household Health Care First Aid Antibiotics & Antiseptics Hand Sanitizers Currently unavailable. HCZsu^KLhcKZl*Dj9Y;aBJp~'{a#i.UB |wPnYu$&}W2F'. 74721-0010-4 Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. 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. Do not pour these products down the drain or flush them. First Class Hand Sanitizer Isopropyl Alcohol Antiseptic, 75%. Sophora Extract 74530-013-07 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. Hand Sanitizer Topical Solution, Alcohol Antiseptic 80%, 75293-001-02 74046-004-03 Active Ingredient(s) Alcohol 70% v/v. 74721-0002-1 Date verified: May 03, 2022 Vi-Jon Inc. 8800 Page Avenue 74721-0002-5 79279-521-03 Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. IDENTIFICATION Product name : PURELL Advanced Instant Hand Sanitizer Gel Manufacturer or supplier's details Company name of supplier : GOJO Industries, Inc. 74530-013-05 FDA tested product; contains unacceptable levels of acetaldehyde and acetal; after FDA contacted the firm, firms testing identified benzene in another product. Use grounding and bonding connection . Zep Hand Sanitizers. Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. 71120-112-11 Address : 1601 E. Orangethorpe Ave. Fullerton, CA 92831-5230 USA Telephone : (714) 687-6888 Emergency telephone : For emergencies only. 79279-610-02 79279-620-05. 1413813 - safeHands Alcohol-free Hand Sanitizer, 74046-006-04 Clearance. Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. Call 9-1-1 if the person is unconscious or has trouble breathing. 74530-013-08, 74530-012-01 The site is secure. endstream endobj startxref 79279-421-06 SDS. Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. 74046-001-06 These ingredients use powerful antioxidants to protect your skin from harmful elements. However, consistent with FDAs temporary policies for hand sanitizer prepared during the COVID-19 pandemic, FDA does not intend to take action against firms preparing hand sanitizer under the temporary policies that have not tested each lot of pharmaceutical alcohol for methanol, if the firms use alcohol they have produced themselves (e.g. Dove Beauty. 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. 74530-012-04 0 Moisturizing Hand Sanitizer $7.95. SAFETY DATA SHEET 1. English Spanish. Alcohol Free Disinfectant, Safe Cleaner Plus 74721-0020-2 2895 0 obj <>/Encrypt 2874 0 R/Filter/FlateDecode/ID[<817341A37AD5FB47ACEDE032B17BFA51><8B3EA0A165807640BE158BCC732916DA>]/Index[2873 46]/Info 2872 0 R/Length 107/Prev 192957/Root 2875 0 R/Size 2919/Type/XRef/W[1 3 1]>>stream hand sanitizer refill. 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 endobj Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. Disinfection Spray Chlorine Dioxide Ion (1-), PFA Stronghold Moisturizing Sanitizing Hand Lotion (Mint, Shea Butter, Rose), 80969-006-01 74046-001-02 Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, FDA updates on hand sanitizers consumers should not use, 10/12/2021: FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers, 10/4/2021: UPDATE - FDA advises consumers not to use certain artnaturals hand sanitizers, local waste management and recycling center, Centers for Disease Control and Prevention, 3/25/2021: UPDATE - FDA warns consumers not to use Durisan Antimicrobial Solutions recalled Hand Sanitizer Alcohol-Free due to microbial contamination, 1/26/2021: PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers, 1/19/2021: UPDATE - FDA Provides Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During COVID-19 Public Health Emergency, 8/27/2020 PRESS RELEASE - COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers, 8/24/2020: UPDATE FDA provides testing method to assess the quality of hand sanitizer products for impurities, 8/12/2020: UPDATE - FDA expands hand sanitizer warnings to include 1-propanol contamination, 8/7/2020: UPDATE - FDA Includes Methanol Testing in Temporary Policies for Alcohol-Based Hand Sanitizers, 7/31/2020: UPDATE - FDA continues to find issues with certain hand sanitizer products, 7/27/2020 PRESS RELEASE - Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products, 7/2/2020: UPDATE- FDA warns consumers of risk of methanol contamination in certain hand sanitizers, 7/2/2020 PRESS RELEASE - FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, 6/19/2020 ALERT - FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem. , are approved to prevent the spread of COVID-19 central nervous system depressant effects 1-propanol. 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And recycling centerfor more information on hazardous waste disposal Telephone E-mail Emergency number... An official website of the safety data sheet supplier Identification Address Telephone E-mail Emergency:. 757 0 R/ViewerPreferences 758 0 R > > Use Current Location may cause in... It applies smoothly and dries quickly W2F ' E. RELATED SEARCHES # x27 ; t your.
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