Label: HAND SANITIZER gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 8, 2023

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  • Active Ingredient

    Ethyl Alcohol 64%

  • PURPOSE

    Antibacterial

  • INDICATIONS & USAGE

    Uses - Hand Sanitizer to help reduce bacteria on the skin. - Recommended for repeated use.

  • WARNINGS

    - For external use only. Flammable, keep away from fire or Flame. - Do not use in eyes. In case of eye contact, flush throroughly with water and seek medical attention. -Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Dispense an adequate amount in your palm to cover all surfaces of hands completely
    • Rub hands together until dry
    • Does not require rinsing
  • OTHER SAFETY INFORMATION

    • Do not store above 105 °F
    • May discolor some fabrics
  • INACTIVE INGREDIENT

    Water, Glycerin, Carbomer, Diisopropylamine, Fragrance

  • PRINCIPAL DISPLAY PANEL

    0.5oz HS 64 Front and Back

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-2073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL64 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-2073-214.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/10/2022
    Labeler - Raining Rose (083819404)
    Registrant - Raining Rose (083819404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemisphere071957146manufacture(65692-2073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose083819404label(65692-2073)
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