Label: HAND SANITIZER gel

  • 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 February 26, 2021

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  • ACTIVE INGREDIENT

    Ethanol 70%

  • PURPOSE

    Antimicrobial

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    Flammable, keep away from fire or flame. For external use only. Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention. Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours. If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    • 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*
    • May discolor some fabrics
  • INACTIVE INGREDIENT

    Water (Aqua), Isopropyl Alcohol, Vanilla Fragrance, Acylates/C10-30 Akyl Acrylate Crosspolymer, Glycerin, Aloe Barbadensis Leaf Juice, Panthenol, Aminomethyl Propanol.

  • PRINCIPAL DISPLAY PANEL

    C10884 Combined-01

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-2063
    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)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE (UNII: QCD5R22RNT)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-2063-144 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2021
    Labeler - Raining Rose, INC (083819404)
    Registrant - Raining Rose, INC (083819404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose083819404pack(65692-2063) , label(65692-2063)
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