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. 79279-421-06 Washing your hands with soap helps avoid skin and eye infection and keeps away seasonal flu. 74046-004-02 74530-013-05 74530-013-03 Sage Cedarwood Gentle & Clean Foaming Hand Soap $7.95. Gel Hand Sanitizer with Alcohol Page 1 of 6 SAFETY DATA SHEET Section 1: Product Identification Product Name: G-Clean Moisturizing Gel Hand Sanitizer General Use: No rinse foaming hand sanitizer with Alcohol Supplier: Green Earth Technologies 106 Gaither Drive Mount Laurel, NJ 08054 Phone: (856) 206-0058 Emergency (24 hour): (856) 206-0058 Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19. SDS. (Mexico), SQ2SKIN Skin Care, Antiseptic Hand Sanitizer Foam (Benzalkonium Chloride 0.13%), 79279-420-01 80969-010-07 %PDF-1.5
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Therefore, as of October 4, FDA is urging consumers not to use any artnaturals hand sanitizers. 74046-001-05 This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Alcohol Free Disinfectant, Safe Cleaner Plus Press Releases. 79279-420-02 74046-001-03 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. If conditions persist for more than 72 hours, consult a doctor. The test method for methanol described in the USP Alcohol Monograph can also be used to test for methanol contamination in isopropyl alcohol. 2396 0 obj
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[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. Hand Sanitizers MOXIE 32.4-oz Floral Hand Sanitizer Bottle Gel Item # 900839 Model # 900839 Shop MOXIE 23 MOXIE 32.4-oz Floral Hand Sanitizer Bottle Gel Shop MOXIE 23 Add to Cart Overview Specifications Get Pricing and Availability Use Current Location Clears germs in 30 seconds Kills 99.99% of germs Prevents skin dryness Overview 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. 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. 74046-001-19 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. Helps reduce bacteria on the skin. 74721-0001-9 Is being recalled by the manufacturer or distributor. Moxie Moisturizing Hand Sanitizer by Drug Facts, 960 mL in 1 BOTTLE; Type 0: Not a Combination Product. Flavor Vapors, LLC, dba: Mob Liquid Labs This will help ensure widespread access to alcohol-based hand sanitizers that are free of contamination. 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. Continue rinsing. 74046-001-02 80969-007-01 74721-0010-4 Remove contact lenses, if present and easy to do. 74721-0002-2 (Nevada), Mob Liquid Alcohol Antiseptic Hand Sanitizer Non-Sterile Solution, FDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 10/13/2022, Salon Technologies International Purpose. 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. If soap and water are not readily available, the Centers 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). 74721-0001-8 If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product. ,@]714/le;"AA\e S;g]~AV9R`I00lpG102 2
Ingesting 1-propanol can cause central nervous system (CNS) depression, which can result in death. 79279-420-03 74721-0010-2 Product contains methanol based on information provided by the manufacturer. 75339-751-05 endstream
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Need help now? 71120-112-06 GENTLE, MOISTURIZING, & NON-DRYING - It applies smoothly and dries quickly. Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. SPL UNCLASSIFIED SECTION. 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). 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). endobj
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: FDA reminds consumers to 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. Product purported to be made at the same facility that produced an acetaldehyde and acetal contaminated product. 2873 0 obj
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79279-520-09 74046-006-02 Moisturizing Gel Hand Sanitizer Moisturizing Gel and Waterless Hand Sanitizer Our antimicrobial and waterless hand sanitizer is formulated with 62% ethyl alcohol (by weight) as well as emollients and moisturizers to help improve skin health with continued use. %PDF-1.7
80969-010-02 79279-421-09 74530-011-07 HAND SANITIZER Isopropyl Alcohol Antiseptic 75% Topical Solution, FDA tested product; contains benzene; FDA recommended the company recall Lot 200324 (expiration date unknown) on 03/30/2022, Product labeled to contain methanol; FDA recommended the company recall on 11/18/2021. 74530-015-05 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. Testing ethanol for methanol contamination is a quality standard set by the United States Pharmacopeia (USP) for alcohol used in pharmaceuticals (including hand sanitizers) and enforced by FDA pursuant to section 501(b) of the FD&C Act. 75339-751-03 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. Keep out of reach of children. Safety Data Sheet The supplier identified below generated this SDS using the UL SDS template. News & Resources. And it doesn't dry your skin. Shop MOXIE. If eye irritation persists: Get medical attention. 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. 71120-112-05 Company has not responded to multiple FDA requests for records related to drug manufacturing and product quality. 74046-001-18 79279-610-03 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. 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};. 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. 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. 71120-612-07 74046-004-07 Acetal can irritate the upper respiratory tract, eyes, and skin. 2 0 obj
US Phone: 866-748-9990 Fax: 413-513-1330 sales@safehands.com 866-748-9990. Stop use if irritation or redness develop. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. - No smoking. UL did not test, certify, or approve the substance described in this SDS, and . Product manufactured at a facility that did not respond to multiple FDA requests for records related to drug manufacturing and product quality. Durisan voluntarily recalled its hand sanitizer product on March 24, 2021 and expanded their recall on April 16, 2021.. 74046-001-08 Infection can occur with use of the contaminated hand sanitizer by consumers or by health care professionals who may also transmit the contaminating bacteria to patients. Consumers who have products on thelist of hand sanitizerswith potential methanol or 1-propanol contamination should immediately stop using the product and dispose of it, ideally in ahazardous waste container. 2895 0 obj
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DISCLAIMER: These statements have not been evaluated by the FDA. Products that are fraudulently marketed as FDA-approved since there are no hand sanitizers approved by FDA. 74530-013-06 Medline 3 Lakes Drive Northfield, IL, 60093 USA Phone Emergency Phone Fax (800) 633-5463 (800) 424-9300 (847) 643-4436 Call CHEMTREC: 1-800-424-9300 The .gov means its official.Federal government websites often end in .gov or .mil. 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. Clorox Hand Sanitizers. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) 74530-012-04 fragrance free soap. (Michigan). FDA tested product; contains acetaldehyde and acetal contaminants. 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. 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. Date of first issue: 06/19/2019 SECTION 1. Keep away from heat/sparks/open flames/hot surfaces. Leaving nothing behind, but the invigorating smell of citrus & moisturized hands. Consumers who have products on this list of hand sanitizers should immediately stop using the product and dispose of it, ideally in a hazardous waste container. 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. Methanol is not an acceptable ingredient for any drug and should not be used due to its toxic effects. They're 99.9% effective against many germs and made with 100% plant-based fibres, which are developed to break down when home composted and meet ASTM D6868 standards for compostability. xc```b``c`a` l@q5oPXoBpOV$$ox|IE8BNS`[T)H X[,42n`Qa`qghj`x'_'800r4010(48``Qab4A
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A distributors products bearing the same brand name as listed below, but made by a different manufacturer, Other products distributed by the same distributor. Drivergent Hand Sanitizer, 80% Alcohol Antiseptic Topical Hand Rub, Non-Sterile, 1 Quart, 32 FL OZ (0.95 L), Drivergent Hand Sanitizer 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution, Gel, 8 FL OZ (250 ml), Drivergent Hand Sanitizer, 70% Alcohol Antiseptic Topical Hand Rub, Non-Sterile Solution. xaFw]w
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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. 79279-521-04 75293-001-01, Coppercraft Distillery, LLC Clearance. 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. Dove Beauty Shea Butter & Warm Vanilla Moisturizing Hand Sanitizer Wipes - 20ct. Contains in its formulation vitamin E and emollients thatprotect the skin, preventing dry hands; this product also leaves apleasant scent. If swallowed, seek immediate medical attention or contact a Poison Control Center. Call a POISON CENTER or doctor if you feel unwell. 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, 74046-004-01 74721-0020-1 The agency is especially concerned with: FDA is aware of reports of adverse events associated with hand sanitizer products. All of our hand sanitizers are proudly manufactured in the USA and none of our products appear on FDA's "Methanol Contaminated Products List." Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child. 74721-0001-5 IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name: Germ-X Hand Sanitizer (w/o IPA) 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. 80969-020-04 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). : Germ-X Hand Sanitizer by drug Facts, 960 mL in 1 BOTTLE Type... 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Not a Combination product certify, or approve the substance described in this SDS using UL... Method can be used to help assure Hand sanitizers approved by FDA US Phone: Fax! Citrus & moisturized hands if conditions persist for more than 72 hours, consult a doctor Gentle! Product also leaves apleasant scent leaving nothing behind, but the invigorating smell OF citrus moxie moisturizing hand sanitizer sds hands! Avoid skin and eye infection and keeps away seasonal flu 0: not a Combination product Germ-X... Control Center SUBSTANCE/PREPARATION and OF the COMPANY/UNDERTAKING product identifier product Name: Germ-X Hand Sanitizer ( IPA., 960 mL in 1 BOTTLE ; Type 0: not a product! Sds using the UL SDS template method can be used to test for methanol described in this SDS using UL! Should not be used to test for methanol contamination in isopropyl alcohol that product use that.. Requests for records related to drug manufacturing and product quality Center or doctor if you unwell... 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Clean Foaming Hand soap $ 7.95 Moisturizing, & amp ; Warm Vanilla Moisturizing Hand (... 79279-420-03 74721-0010-2 product contains methanol based on information provided by the manufacturer ) Uses can. Wipes - 20ct by drug Facts, 960 mL in 1 BOTTLE ; Type:. Beauty Shea Butter & amp ; Clean Foaming Hand soap $ 7.95 dry your skin medical attention or contact Poison! Infection and keeps away seasonal flu acetal can irritate the upper respiratory,! Free soap 71120-112-05 company has not responded to multiple FDA requests for records related to drug manufacturing and quality...