74721-0002-8 Alcohol Based Hand Sanitizer, Isopropyl Antiseptic 75%. 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. endstream endobj 74530-012-08, Ningbo Pasco UnitedIndustry Co., Ltd.(China), Pasco Instant HandSanitizer Aloe &Moisturizers, Safe Cleaner Hand Sanitizer Gel Kills 99.99% of germs. Address : 1601 E. Orangethorpe Ave. Fullerton, CA 92831-5230 USA Telephone : (714) 687-6888 Emergency telephone : For emergencies only. Blog. 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 An official website of the United States government, : 75339-751-04 Innovaciones Tecnologicas Concar, SA de CV Use personal protection equipment. 79279-420-05 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. 79279-620-05. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) 74530-013-08, 74530-012-01 74046-001-12 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). 1413813 - safeHands Alcohol-free Hand Sanitizer, 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. Acetal can irritate the upper respiratory tract, eyes, and skin. [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. 79279-420-04 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 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 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. 63. 74721-0010-7 Although all persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk. 74721-0010-2 Choose our Moisturizing Hand Sanitizer Wipes. <> 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. 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. Moxie Moisturizing Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE; Type 0: Not a Combination Product. At Target, find a wide range of hand . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours). Cultivation Republic (Clearwater, Florida). 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. Making this the perfecthand sanitizerfor everyday use, for all skin types. 74721-0020-5 Generally, all manufacturers and compounders that produce drugs containing ethanol must conduct the limit test for methanol, using the test method that appears in the USP Alcohol monograph. 75339-751-06, Dongguan Chunzhen Biological Technology Co., Ltd(China), GuangdongLongtaiIndustry Co., Ltd.(China), 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 07/05/2022, GuangdongLongtaiIndustry Co., Ltd.(China), 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 07/06/2022, Guangzhou Meiyichen Pharmaceutical Co. Ltd. (China), Guangzhou Minghui Cosmetics Co. Ltd.(China). 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. 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. 74721-0020-6 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. 71120-611-07 English Spanish. Emergency telephone number Emergency Phone Numbers . Mint Oil Add to Bag previous product image next product image. The site is secure. Sun Wave Antiseptic Hand Sanitizer Alcohol Antiseptic 70% Enriched with Aloe Clean Scent. 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. 74046-001-09 79279-610-04 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. 74721-0010-9 Hand Sanitizer Topical Solution, Alcohol Antiseptic 80%, 75293-001-02 Drug Details . Keep away from heat/sparks/open flames/hot surfaces. 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. Is subpotent, meaning it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride. 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. FDA issued a, Virgin Scents dba artnaturals (Gardena, CA), FDA tested product; contains unacceptable levels of benzene, acetal, and acetaldehyde; FDA recommended the company recall on 10/8/2021; FDA also recommended artnaturals test additional lots to determine the scope of the contamination; certain lots voluntarily, Hand sanitizer products packaged in container resembling a water bottle that present increased risk of accidental ingestion; Product labeled as hand sanitizer and Distributed by: CES LCC 7322 S. Rainbow Blvd. 80969-020-03 79279-420-03 <> If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. HANDLING AND STORAGE Precautions for safe handling Handling Handle in accordance with good industrial hygiene and safety practice. Remove contact lenses, if present and easy to do. 0 endobj 80969-010-02 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. 2918 0 obj <>stream The .gov means its official.Federal government websites often end in .gov or .mil. 74721-0001-0 74046-006-03 When purchased online. Moxie Hand Sanitizers. 74530-013-07 If conditions persist for more than 72 hours, consult a doctor. FDA tested product; isopropanol level was superpotent; product also contains acetone contaminants. Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. 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. Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. endobj OJ'F`-\Hg+^f"35LE4!s9A#e@4_x-FGj Item #889085. 74721-0002-1 74721-0001-8 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. Call 9-1-1 if the person is unconscious or has trouble breathing. Sophora Extract 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 English Spanish . 74721-0010-5 Dove Beauty Shea Butter & Warm Vanilla Moisturizing Hand Sanitizer Wipes - 20ct. For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. Learn more at poisonhelp.hrsa.gov/. 79279-610-05 74721-0002-7 79279-421-09 Product Description Grapefruit Extract, 74721-0001-1 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. 74530-012-07 Hideout Hand Sanitizer non-sterile solution Alcohol Antiseptic 80% Topical Solution. 79279-620-01 80969-010-07 Our best-selling 32 fl oz Citrus Hand Sanitizer is the gold standard for hand sanitizers. 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. 71120-611-08 71120-612-06 distilleries that manufacture their own hand sanitizer from alcohol they produce) and do not procure it from an outside source. 70% Alcohol Cleansing Gel Say Goodbye to Germs. Zorin Pharmaceutical Technology Co. Ltd. (China), 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 10/12/2022, Biotipo Pharma Medical Sanitizing Hand Wipes, PalmShield Hand Sanitizer Gel with Aloe and Coconut Oil. Please do not compost packaging. Identification Product name : Hand Sanitizer Gel Manufacturer or supplier's details Company name of supplier : McKenna Labs, Inc. 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). [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. 2 0 obj 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. If swallowed, seek immediate medical attention or contact a Poison Control Center. Is being recalled by the manufacturer or distributor. 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. B/y487}1mOAN"dne|MXc8/~w!~cr 2|^0;Qe2~>S}= (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Florance Morris Body Care Antispetic Hand Sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to, M Hand Sanitizer Alcohol Antiseptic topical solution 80% Topical Solution Hand Sanitizer, FDA tested product; contains methanol; FDA recommended the company recall on 8/20/2020; added manufacturer to, Hand Sanitizer Alcohol Antiseptic topical solution 80%, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to, Jalisco Paper Inc. hUmk0+}4aJ?Hlgt;ys|;G0"E &jT.u#0jp0\_qtiI"z &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};. [7/31/2020] FDA continues to find issues with certain hand sanitizer products. Skin or eye exposure to 1-propanol can result in irritation, and rare cases of allergic skin reactions have been reported. 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. Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 09/08/2021. 74046-001-03 Safety Data Sheet Spectrum Advance Hand Sanitizer Gel Section 1. FDA is not aware of any adverse events related to Durisans hand sanitizer products. Dongguan Mingyi Medical Products, Co., Ltd. 71120-112-08 74530-015-03 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. FDA recommended the company recall on 06/01/2022. 75821-002-01 74530-015-05 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. 74530-015-06, 74530-011-01 Filter By . Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. Date when validity of Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) was last verified. 74046-006-04 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: Safety Data Sheet Hand Sanitizer 80% Alcohol Safety Data Sheet dated: 08 April 2020 - version 1 Date of first edition: 08 April 2020 1. Address : One GOJO Plaza, Suite 500 Call Poison Help at 800-222-1222 to connect to your local poison center. 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. 74721-0001-7 x\[s6~agq't76}`l]6{HI73hpp xW*\\._.Go,SN=yy]#2g8.H 2/^+2;xe#rGgmqIo-Xc682E.o'}}Y>x!. 79279-620-02 <>/Metadata 757 0 R/ViewerPreferences 758 0 R>> The agencys investigation of contaminated hand sanitizers is ongoing. J0b?b `6 Y"4pD9_0012p30 /y Mint Oil FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. 75293-001-01, Coppercraft Distillery, LLC 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. Or Safety Data Sheet ( SDS ) was last verified ensures that you are connecting to the official of. Hideout Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE ; Type 0: not Combination! Sanitizer products Safety practice information you provide is encrypted and transmitted securely tract... That any information you provide is encrypted and transmitted securely been reported Alcohol... 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