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. The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. Proton Armor Antimicrobial Alcohol-Free Foaming Hand Sanitizer. The agency will provide additional information as it becomes available. Kills germs in 30 seconds. 74046-001-15 OJ'F`-\Hg+^f"35LE4!s9A#e@4_x-FGj 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). Flavor Vapors, LLC, dba: Mob Liquid Labs 74721-0002-2 63. Kills 99.99% of germs. 74721-0020-6 80969-010-06 When purchased online. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. And it doesn't dry your skin. Sophora Extract 74721-0002-5 distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. 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 9/2/2022. SAFETY DATA SHEET 1. - No smoking. The site is secure. 74046-004-05 2030 0 obj <>stream 74530-013-04 The .gov means its official.Federal government websites often end in .gov or .mil. endstream endobj startxref Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. Keep away from heat/sparks/open flames/hot surfaces. 74530-013-08, 74530-012-01 Grapefruit Extract, 74721-0010-1 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. Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. 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. 74530-011-04 <>/Metadata 757 0 R/ViewerPreferences 758 0 R>> Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. 74721-0010-6 . Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. Before sharing sensitive information, make sure you're on a federal government site. 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. 79279-620-01 74046-001-14 79279-521-01 79279-520-06 Dongguan Mingyi Medical Products, Co., Ltd. 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. J0b?b `6 Y"4pD9_0012p30 /y 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 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. 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. 79279-420-02 Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. FDA encourages health ce 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): [7-2-2020] FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer productsthat are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. 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): The following chart outlines the information on hand sanitizer labels for consumers to use to identify a product that: FDA advises consumers not to use hand sanitizers produced by the manufacturers identified in the table below. Company tested product; contains benzene. IDENTIFICATION Product name : Scott Moisturizing Foam Hand Sanitizer Product code : 91590 Manufacturer or supplier's details Company : Kimberly -Clark Corporation 50 Burnhamthorpe Rd W . These ingredients use powerful antioxidants to protect your skin from harmful elements. 74530-011-07 This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. 74721-0001-2 80969-040-04, PFA Stronghold Hand Sanitizer 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). endstream endobj 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. 2424 0 obj <>stream Identification Product Identifier Synonyms Manufacturer Stock Numbers Recommended use Uses advised against . 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. Use Current Location. endobj x\mSc3t:;w@q_%[vLIGM9?_LbQ.1vOUh*{[ObRO/nP):=(?j>F( PROVON Moisturizing Hand & Body Lotion. Purpose. 74530-011-06 The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. Hand Soap. hand sanitizer refill. Address : 1601 E. Orangethorpe Ave. Fullerton, CA 92831-5230 USA Telephone : (714) 687-6888 Emergency telephone : For emergencies only. %PDF-1.5 % 74721-0001-6 74046-004-03 Moxie Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L G Sourcing, Inc.. Drug facts, warnings, and ingredients follow. If conditions persist for more than 72 hours, consult a doctor. 74530-015-02 FDA tested product; contains acetaldehyde and acetal contaminants; FDA recommended a recall on 3/29/2022. Innovaciones Tecnologicas Concar, SA de CV 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. 74721-0001-7 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. [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. 79279-620-05. 2918 0 obj <>stream 79279-421-09 %%EOF SAFETY DATA SHEET PURELL Advanced Instant Hand Sanitizer Gel Version 1.0 SDS Number: 400000000417 Revision Date: 08/02/2020 1 / 12 SECTION 1. 80969-007-01 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. 74721-0010-2 74721-0002-6 Date verified: May 03, 2022 Vi-Jon Inc. 8800 Page Avenue 74530-011-03 hb``` ea pGeo,N)v00rd8RW @ 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. 79279-610-03 It rubs in clean without any of that goopy after feel. 74721-0002-8 1413813 - safeHands Alcohol-free Hand Sanitizer, SAFETY DATA SHEET Scott Moisturizing Foam Hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS Number: . Individuals with compromised immune systems are at increased risk. 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. Add to Bag previous product image next product image. 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 79279-421-08 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. FDA is not aware of any adverse events related to Durisans hand sanitizer products. HAZARDS . by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. 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. 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. Products labeled with harmful or poisonous ingredients, such as methanol. <> HANDLING AND STORAGE Precautions for safe handling Handling Handle in accordance with good industrial hygiene and safety practice. . 74046-006-08 FDA recommended the company recall all drug products on 12/12/2022. Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. 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. 71120-117-02, 75821-001-01 74046-001-04 Place directly on hand and rub in thoroughly. )2EQJdQ.$fQ#q{RX?H!B9 hB.>`#>u) Alcohol Antiseptic, 80% Topical Solution, Hand Sanitizer, Non-Sterile Solution. Stop use if irritation or redness develop. 71120-612-06 Please do not compost packaging. [8/24/2020] FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products. Benzene may cause certain types of cancer in humans. 74046-001-19 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. Consumers should be aware that FDAs recommendation against using a distributors specific hand sanitizer product(s) manufactured by a particular manufacturer, as listed below, does not extend to: If a product on the list below does not identify the manufacturer on the label, consumers can contact the distributor whose name appears on the label to find out who manufactured the product. endobj 79279-620-04 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. 32 Fl Oz (Pack of 4) . 74046-006-02 79279-610-05 74046-001-06 Moisturizing formula with vitamin E. RELATED SEARCHES. 74530-013-05 Company tested product lot 2004090090; 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. xaFw]w H1#nz 74046-001-03 IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. MOXIE 24-oz Aloe Hand Sanitizer Bottle Gel. 75339-751-04 Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Use grounding and bonding connection . Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. 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 74721-0010-5 Page 1 / 10 . 1187. . 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. 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. Dove Beauty Shea Butter & Warm Vanilla Moisturizing Hand Sanitizer Wipes - 20ct. 74721-0010-7 FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/10/2020; added manufacturer to, Product purported to be made at the same facility that produced an subpotent product; FDA recommended the company recall on 11/10/2020; added manufacturer to, Protec Hands Antibacterial Gel Topical Solution Non-sterile Solution, Smart Care hand sanitizer packaged in 0.84 fl oz. Durisans hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. 80969-020-04 79279-610-04 71120-611-07 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.
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