Label: GUARD- alcohol gel

  • NDC Code(s): 63148-502-08
  • Packager: Apollo Health and Beauty Care
  • 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 16, 2023

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  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    For personal hand hygine to help prevent 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 Poison Control Center immediately.

  • Directions

    • For occassional and Personal use.
    • Rub thoroughly into hands for at least 30 seconds. Allo to dry.
    • Children under 6 years should be supervised when using this 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.

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    GUARD 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-502
    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)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-502-08227 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2023
    Labeler - Apollo Health and Beauty Care (201901209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63148-502)
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