80969-020-03 endstream endobj GENTLE, MOISTURIZING, & NON-DRYING - It applies smoothly and dries quickly. The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. IDENTIFICATION Product name : Scott Moisturizing Foam Hand Sanitizer Product code : 91590 Manufacturer or supplier's details Company : Kimberly -Clark Corporation 50 Burnhamthorpe Rd W . 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 show acetaldehyde may cause cancer in humans and may cause serious illness or death. Identification Product Identifier Synonyms Manufacturer Stock Numbers Recommended use Uses advised against . 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. 32 Fl Oz (Pack of 4) . Innovaciones Tecnologicas Concar, SA de CV 74046-001-07 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. 74530-011-05 74530-012-07 Cart 80969-040-04, PFA Stronghold Hand Sanitizer Wet hands thoroughly with product and allow to dry without wiping. 74046-001-15 FDA recommended the company recall all drug products on 12/12/2022. Hand Sanitizer Topical Solution, Alcohol Antiseptic 80%, 75293-001-02 [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. Details of the supplier of the safety data sheet Supplier Address . 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. Acetal can irritate the upper respiratory tract, eyes, and skin. 74530-011-04 75339-751-04 74530-012-04 74721-0001-9 Drivergent Hand Sanitizer, Alcohol Antiseptic 80% Topical Solution, Antiseptic Hand Rub, Non-Sterile Solution. 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. SAFETY DATA SHEET Scott Moisturizing Foam Hand Sanitizer Version 1.2 Revision Date: 03/02/2020 SDS Number: . Dove Beauty. 74530-013-06 Denaturing alcohol in hand sanitizers is critical to deter children from unintentional ingestion. 74046-001-13 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. For questions, contact FDA: COVID-19-Hand-Sanitizers@fda.hhs.gov. Grapefruit Extract, 74721-0010-1 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. 74721-0010-5 Dongguan Mingyi Medical Products, Co., Ltd. (China), 74046-001-01 SAFETY DATA SHEET PURELL Advanced Instant Hand Sanitizer Gel Version 1.0 SDS Number: 400000000417 Revision Date: 08/02/2020 1 / 12 SECTION 1. B/y487}1mOAN"dne|MXc8/~w!~cr 2|^0;Qe2~>S}= 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. Date of first issue: 06/19/2019 SECTION 1. Making this the perfecthand sanitizerfor everyday use, for all skin types. Product Description Cultivation Republic (Clearwater, Florida). While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated,FDA urges consumers not to drink any of these products. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) 74046-006-08 Hand Sanitizer Revision Date 02-Apr-2020 7. by artnaturals Gardena, CA 90248 and found unacceptable levels of benzene, acetaldehyde, and acetal contaminants. 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 The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. PURELL Healthcare Advanced Hand Sanitizer Gentle and Free Foam ES6 Starter Kit - DISCONTINUED. 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. 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. 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. 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 Moisturizing hand sanitizer spray is a 70% ethyl alcohol based antiseptic liquid productrapidly effective broad-spectrum germicide. 79279-620-04 74721-0002-5 74721-0020-1 75339-751-03 79279-520-08 MOXE Hand Sanitizer is a blend of 70% alcohol with Aloe Vera and Vitamin E, to enhance your skin's moisture. hand sanitizer refill. Topical Solution. Address : One GOJO Plaza, Suite 500 Model #20-21838. 74046-001-03 75293-001-01, Coppercraft Distillery, LLC 74721-0001-2 Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. 0 74046-001-18 Antiseptic. 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. 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. 74046-001-12 2873 0 obj <> endobj Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 79279-521-03 Page 1 / 10 . Water (aqua), glycerin, carbomer, triethanolamine, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benoate. 79279-520-06 Dongguan Mingyi Medical Products, Co., Ltd. Medline 3 Lakes Drive Northfield, IL, 60093 USA Phone Emergency Phone Fax (800) 633-5463 (800) 424-9300 (847) 643-4436 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. 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. Consumers who have been exposed to hand sanitizer containing 1-propanol and are experiencing symptoms should seek immediate care for treatment of toxic effects of 1-propanol poisoning. 74721-0020-7 74046-006-10. Distributors often do not identify the manufacturer on the product label and are not required to do so under federal law. Continue rinsing. 80969-010-02 74046-001-17 Has been tested by FDA and found to contain methanol, 1-propanol, benzene, acetaldehyde, or acetal. Softsoap. Press Releases. Learn more at poisonhelp.hrsa.gov/. 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. 79279-420-05 %PDF-1.5 % 74721-0020-2 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. 74046-001-06 Use grounding and bonding connection . Details of the supplier of the safety data sheet Supplier Name Vi-Jon Inc. 75339-751-05 74046-004-10, Benzalkonium Chloride Instant Hand Sanitizer, 74046-006-01 74721-0020-5 75821-001-03 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. <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 16 0 R] /MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> The dangers of drinking any hand sanitizer under any conditions. 74530-012-06 Young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. 74530-013-07 2424 0 obj <>stream FDA will consider revising the list as appropriate. Is packaged in a container that resembles a food/beverage container that presents increased risk of accidental ingestion. 74721-0020-9, 71120-112-01 Herbacil Antiseptic Hand Sanitizer 70% Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 7/24/2020; product voluntarily, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily, Soho Fresh Hand Sanitizer Gel Antibacterial, FDA tested product; contains methanol; FDA recommended the company recall on 9/15/2020; added manufacturer to, SOHO Fresh Hand Sanitizer Gel Antibacterial, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/15/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; Product voluntarily recalled by, CALA Advanced Hand Sanitizer with Aloe Vera Extract, FDA-tested product; contains benzene; FDA recommended the company recall Lot 2004718 (Expiration 04/2023) on 12/27/2021; FDA expanded recall on 2/25/2022 to include all hand sanitizer drug products manufactured at the facility; added manufacturer to, Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced, FDA tested product; contains methanol; product retained at the border; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, FDA tested product; contains methanol; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to, DEPQ Internacional S de RL de CV (Mexico), FDA tested product; benzalkonium chloride level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to, dgreen Advanced Hand Sanitizer Antibacterial Gel, Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to, FDA tested product; contains methanol; addedmanufacturerto, Product purported to be made at the same facility that produced methanol contaminated product; addedmanufacturerto, Distribuidora Lagunera del Norte SA de CV (Mexico), FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to, Distribuidora Lagunera del Norte SA de CV, FDA tested product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to, Cleaner by Crystalware Hand Sanitizer Alcohol Gel, FDA tested product; FDA recommended the company recall on 8/21/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/21/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to, CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol, FDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by, Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to, The Good Gel Antibacterial Gel Hand Sanitizer, CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol, Estrategia Hospitalaria SA de CV (Mexico), FDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to, Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/8/2020; added manufacturer to, Genesis Partnership Company SA (Guatemala), FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/27/2020; added manufacturer to, Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to.

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