Label: DMM VISSION HAND SANITIZER ALCOHOL- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 13, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENTS:

    ETHYL ALCOHOL 70%

    PURPOSE:

    ANTISEPTIC

  • USES:

    hand sanitizer to help decrease bacteria on the skin.  When water, soap and towel are not available.

  • WARNINGS:

    For external use only. Flammable, keep away from fire or flame.

    Do not apply around the eyes. Do not use in ears or mouth. When using this product, avoid contact with eyes, in case of contact, flush eyes with water.

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor, if redness or irritation develops and persists for more than 72 hours.

    Keep out of reach of children. Children must be supervised in use of this product.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: pump as needed into your palms thoroughly spread on both hands, rub into skin until dry.

  • SPL UNCLASSIFIED SECTION

    Other information: store at 20’ C (66’ to 77’ F); May discolor fabrics.

  • INACTIVE INGREDIENT

    Inactive ingredients: Distilled water, Ethyl Alcohol 96º, Carbopol, Glicerine, Vitamina E, Triethanolamine.

  • Package Labeling

    Label

  • INGREDIENTS AND APPEARANCE
    DMM VISSION HAND SANITIZER ALCOHOL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75799-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75799-000-041200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/05/2020
    Labeler - DMM Vission, S.A. de C.V. (951576596)
    Establishment
    NameAddressID/FEIBusiness Operations
    DMM Vission, S.A. de C.V.951576596manufacture(75799-000) , label(75799-000)
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