Label: AMERIDERM FOAM ALCOHOL HAND SANITIZER- ethyl alcohol liquid

  • 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 June 8, 2016

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  • DRUG FACTS

    Ethyl Alcohol 70%

    Antibacterial

  • Uses

    • for sanitizing to reduce bacteria on skin
  • WARNINGS

    FOR EXTERNAL USE ONLY

    Flammable: Keep away from fire or flame

  • When using this product

    • avoid contact with eyes. In case of eye contact, flush eyes with water
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • apply one shot of foaming sanitizer to dry hands
    • rub into skin
    • no rinsing required
  • INACTIVE INGREDIENT

    BIS-PEG-12 Dimethicone, Isopropyl Alcohol, PEG-12 Dimethicone Crosspolymer, Propylene Glycol, Water

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    AMERIDERM FOAM ALCOHOL HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-8080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-8080-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/25/2016
    Labeler - Shield Line LLC (078518916)
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