Label: DERMAMED NATURAL HAND SANITIZER- ethanol 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 April 24, 2020

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70% v/v

  • PURPOSE

    Antimicrobial

  • WHEN USING

    Hand sanitizer to help reduce bacteria on the skin that could cause disease
    Recommended for repeated use

  • WARNINGS

    Flammable. Keep away from fire or flame.

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Place enough product in your palm to thoroughly cover your hands
    Rub hands together briskly until dry
    No rinsing required
    No towels needed

  • INACTIVE INGREDIENT

    Water, Aloe Vera Juice, Glycerin, Isopropyl Myristate,Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Aminomethyl Propanol, Propylene Glycol, Fragrance

  • KEEP OUT OF REACH OF CHILDREN

  • ASK DOCTOR

  • DOSAGE & ADMINISTRATION

  • PRINCIPAL DISPLAY PANEL

    24010030 ml

  • INGREDIENTS AND APPEARANCE
    DERMAMED NATURAL HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    WATER (UNII: 059QF0KO0R)  
    1,2-PROPANEDITHIOL (UNII: GS64223D79)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69711-800-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
    2NDC:69711-800-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
    3NDC:69711-800-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
    4NDC:69711-800-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
    5NDC:69711-800-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/28/2020
    Labeler - Biological Health Group (079767886)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaMed Pharmaceutical Inc.202617023manufacture(69711-800)
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