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IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores.
Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. 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. 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. hUmk0+}4aJ?Hlgt;ys|;G0"E
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&x%MIXzmWouAyIxOF]8OI]Td9N[Gu*ID9~*/>][]%(6=cmV:QE&yeW6DsNMv^oC\GRV=b]t Wn\Erx'yQN7q@B@,KCwa0UCR9Z5(R/iYYOg}HeQ]~\>*BZ#Xq1! ! O B{\32Dyu#a6Rd2O};. FDAs investigation of methanol in certain hand sanitizers is ongoing. 74721-0010-5 70% Alcohol Cleansing Gel Say Goodbye to Germs. 74721-0001-9 SPL UNCLASSIFIED SECTION. 75293-001-04 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. Moisturizing formula with vitamin E. RELATED SEARCHES. Do not pour these products down the drain or flush them. MOXE Hand Sanitizer is a blend of 70% alcohol with Aloe Vera and Vitamin E, to enhance your skin's moisture. FDA tested product; contains methanol; product voluntarily recalled on 11/5/2022. These ingredients use powerful antioxidants to protect your skin from harmful elements. Dongguan Mingyi Medical Products, Co., Ltd. At Target, find a wide range of hand . FDA issued, Alcohol Isopropilico Hand Sanitizer Limar, Hand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/16/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 6/30/2021;product, Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe, FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; added manufacturer to, BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E, FDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to, MODESA Instant Hand Sanitizer Moisturizers and Vitamin E, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily, BLUMEN Advanced Instant Hand Sanitizer Lavender, BLUMEN Clear LEAR Advanced Hand Sanitizer, BLUMEN Clear Advanced Instant Hand Sanitizer, BLUMEN Clear Advanced Instant Hand Sanitizer Aloe, BLUMEN Clear Advanced Instant Hand Sanitizer Lavender, BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol, Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol, Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol, Blumen Antibacterial Fresh Citrus Hand Sanitizer, Hello Kitty Hand Sanitizer; this is not an official Sanrio licensed product, Assured Instant Hand Sanitizer (Vitamin E and Aloe), Assured Instant Hand Sanitizer (Aloe and Moisturizers), Assured Instant Hand Sanitizer Vitamin E and Aloe, Assured Instant Hand Sanitizer Aloe and Moisturizers, BLUMEN Instant Hand Sanitizer Fragrance Free, FDA tested product; contains methanol; FDA recommended the company recall on 7/2/2020; added manufacturer to, bio aaa Advance Hand Sanitizer 480 mL bottles, Product purported to made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/26/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended a recall on 7/27/2020; product voluntarily, NuuxSan Instant Antibacterial Hand Sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily, Assured Instant Antiseptic Hand Sanitizer with Aloe and Moisturizers, Assured Instant Antiseptic Hand Sanitizer with Vitamin E and Aloe, Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Aloe Vera, Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Vitamin E, Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 8/31/2020; added manufacturer to, Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico), Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to, FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/5/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to, DermX70 Hand Sanitizer (only includes 250mL, 500mL and 1000mL sized packages), SBL Brands LLC dba Global Sanitizers LLC (Nevada) LLC dba Global Sanitizers LLC (Nevada), Protz Real Protection Antibacterial Hand Sanitizer, FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product, 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, AltaioHand Sanitizing Wipes (80% Ethanol), 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;addedmanufacturerto, AltaioHand Sanitizing Wipes (70% Ethanol), Naturia Professional Green Hand Sanitizer, Essentials by Urban Secrets Hand Sanitizer, Essentials by Urban Secrets Advanced Hand Sanitizer, Botanicals Internacional SA de CV (Mexico), Alcohol Antiseptic 80% topical solution hand sanitizer, Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to, Inatek Hand Sanitizer Non-Sterile Solution 70% of Alcohol, FDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to, Total Pure Alcohol Based Hand Sanitizer Gel, Bottle Tree Beverage, LLC, dba: Cathead Distillery (Mississippi). Sophora Extract 79279-610-02 79279-420-05 Grapefruit Extract, 74721-0010-1 Page 1 / 10 . Restaurant Supplies Hand Sanitizer, FDA tested product; ethyl alcohol level was subpotent; product was manufactured at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to, Yacana Alcohol Antiseptic 70% Topical Solution, FDA tested product; contains methanol; FDA recommended the company recall on 8/12/2020; product voluntarily, Yacana Isopropyl Alcohol Antiseptic 70% Topical Solution, FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 8/12/2020; product voluntarily, Yacana Clase Mundial Isopropyl Alcohol Antiseptic 70% Topical Solution or Gel, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/12/2020; product voluntarily, Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China), FDA tested product; contains methanol; product voluntarily recalled by, Guangdong Kemei Pharmaceutical Technology Co. Ltd, KLEAN KARE Hand Sanitizer Industrial and Hospital Grade, Essentials, M.D. The alcohol (ethanol) or IPA should be destroyed following guidelines for hazardous waste and the manufacturer or compounder should contact FDA regarding the test results and the alcohols source. Call 9-1-1 if the person is unconscious or has trouble breathing. Product manufactured under insanitary conditions with potential for cross contamination with dangerous industrial chemicals. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Is made at a facility that did not respond to multiple FDA requests for information about the quality of their products and manufacturing process. 74046-001-12 79279-620-03 74530-011-05 74721-0002-7 While the exact risk from using hand sanitizer containing benzene, acetaldehyde, or acetal is unknown, FDA recommends consumers do not use products contaminated with unacceptable levels of benzene, acetaldehyde, or acetal. Call a POISON CENTER or doctor if you feel unwell. Grapefruit Extract, 74721-0001-1 HAZARDS . 79279-620-02 For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. Moxie Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L G Sourcing, Inc.. Drug facts, warnings, and ingredients follow. 3 0 obj
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Date of first issue: 06/19/2019 SECTION 1. 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. Moisturizing Hand Sanitizer $7.95. 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. product voluntarilyrecalledon 11/30/2021, Product labeled to contain methanol; FDA recommended the company recall on 12/6/2021; product voluntarily recalled on 12/6/2021, 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, Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality even after receiving a warning letter. hand sanitizer 12oz. 74530-011-02 Guangdong Theaoson Technology Co. Ltd. (China), Guangdong Theaoson Technology Co., Ltd. 74721-0001-5 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. 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. Water (aqua), glycerin, carbomer, triethanolamine, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benoate. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. FDA updates on hand sanitizers consumers should not use Need help now? SDS. 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 74530-011-08, 74530-013-01 74721-0010-2 The agency also included an additional denaturant formula in the temporary guidances. Is being recalled by the manufacturer or distributor. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. 74046-001-10 71120-611-07 4.1 out of 5 stars with 1187 ratings. 79279-610-03 Before sharing sensitive information, make sure you're on a federal government site. 79279-610-01 79279-620-01 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). These products are not intended to diagnose, treat, cure, or prevent any disease. PURELL Healthcare Advanced Hand Sanitizer Gentle and Free Foam ES6 Starter Kit - DISCONTINUED. FDA tested product; contains unacceptable levels of acetaldehyde and acetal; FDA recommended the company recall on 10/18/2022; Company did not adequately respond to FDA requests for records and other information related to drug manufacturing, product quality and scope of the contamination. It rubs in clean without any of that goopy after feel. 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. Hand sanitizer No information available. DISCLAIMER: These statements have not been evaluated by the FDA. 71120-117-02, 75821-001-01 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. 71120-112-11 79279-520-06 Item #889085. 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. UL did not test, certify, or approve the substance described in this SDS, and . 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. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. - No smoking. Identification Product name : Hand Sanitizer Gel Manufacturer or supplier's details Company name of supplier : McKenna Labs, Inc. 74530-015-02 Hand Sanitizer Topical Solution, Alcohol Antiseptic 80%, 75293-001-02 Making this the perfecthand sanitizerfor everyday use, for all skin types. 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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. Address : 1601 E. Orangethorpe Ave. Fullerton, CA 92831-5230 USA Telephone : (714) 687-6888 Emergency telephone : For emergencies only. 74046-006-09 Moxie Hand Sanitizers. (Florida), Salon Technologies International Sanitizing Hand Spray 80%. Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. 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. 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. 74046-001-06 Dove Beauty Shea Butter & Warm Vanilla Moisturizing Hand Sanitizer Wipes - 20ct. xc```b``c`a` l@q5oPXoBpOV$$ox|IE8BNS`[T)H X[,42n`Qa`qghj`x'_'800r4010(48``Qab4A
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SAFETY DATA SHEET Kleenex Ultra Moisturizing Foam Hand Sanitizer Version 1.0 Revision Date: 02/25/2020 SDS Number: N00103460403 Date of last issue: - Date of first issue: 02/25/2020 Carbon dioxide (CO2) Unsuitable extinguishing media : Water spray jet Specific hazards during fire fighting : Highly flammable liquid and vapor. Kills germs in 30 seconds. Blaster Hand Sanitizers. 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. 74530-012-06 71120-612-07 For more information, visit Is Your Hand Sanitizer on FDAs List of Products You Should Not Use? 80969-008-01, 80969-010-01 74046-006-08 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. 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. 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. Animal studies indicate that the central nervous system depressant effects of 1-propanol are 2 to 4 times as potent as alcohol (ethanol). 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. 74046-004-07 MOXIE 24-oz Aloe Hand Sanitizer Bottle Gel. 74046-006-10. Contact yourlocal waste management and recycling centerfor more information on hazardous waste disposal. Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. Anti-Bac Hand Sanitizer 70% alcohol, Born Basic. Perineal Care Cream. Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. 79279-520-08 Need help now? The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market. Product Number: 849AA Product Name: Moisturizing Hand Sanitizer Issuing Date: April 11, 2019 Revision Date: March 13, 2020 Revision Number: 1 Page 2 / 11 2. $2.54 reg $2.99. 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