Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 63148-632-02, 63148-632-08, 63148-632-10
  • 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 April 5, 2022

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  • Active Ingredient(s)

    Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Uses

    For personal hand hygiene 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.

    When using this Product

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

    Do not use

    • on children less than 2 months of age.
    • on open skin wounds.
    • on broken or dsamaged skin.

    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

    • Place sufficient product on hands to cover all surfaces and rub until dry for a period of 30 seconds.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

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

  • Questions or comments?

    1-866-695-3030

  • Package Label - Principal Display Panel (NC 2OZ)

    NC 2OZ

  • Package Label - Principal Display Panel (NC 1G)

    NC 1G

  • PDP 8 FL OZ

    PDP 8 FL OZ

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-632
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    BASIC BLUE 1 (UNII: 92N74OA24D)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-632-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2021
    2NDC:63148-632-103780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2021
    3NDC:63148-632-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2021
    Labeler - Apollo Health and Beauty Care (201901209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63148-632)
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