Label: ETHYL ALCOHOL- alcohol gel

  • NDC Code(s): 63148-160-08
  • Packager: Apollo Health and Beauty Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 3, 2024

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  • Active Ingredent

    Ethanol (70%)

  • Purpose

    Antiseptic

  • Uses

    For Personal hand hygiene to help the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

  • Warnings

    For external use only

    • Flammable
    • Keep away from source of heat or fire.

    Do not use

    • on infants less than 2 months of age.
    • on open skin wounds.
    • on broken or damaged skin.

    When using this product avoid

    • Contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • Do not inhale.

    Stop use and ask a doctor

    if irritation or redness develops and lasts.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • For occasional and personal use.
    • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
    • Children under 6 years should be supervised when using thiis product.

  • Inactive Ingredients

    Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Fragrance (Parfum), Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Yellow 5 (CI 19140), Blue 1 (CI 42090).

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ETHYL ALCOHOL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-160
    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
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    DIRECT BLUE 1 (UNII: 8NN34MAQ6H)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-160-08227 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/01/2024
    Labeler - Apollo Health and Beauty Care (201901209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63148-160)
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