Label: HAND SANITIZER- ethyl alcohol 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 December 14, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients
    Alcohol 62%

  • PURPOSE

    Purpose
    Antiseptic

  • WARNINGS

    Warnings

    Flammable, keep away from open flame and sources of heat. For external use only. Do not ingest.

    Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention.

  • STOP USE

    Stop use and ask doctor if irritation and redness develops and persists for more than 72 hours. Do not use if you are allergic to any ingredients.

  • 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

    • Use 1.5mL and rub thoroughly into hands for at least 30 seconds. Allow to dry.
    • Does not require rinsing.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadenis Leaf Juice, Glycerin, Propylene Glycol, Vanilla Fragrance, Water.

  • INDICATIONS & USAGE

    Use

    • Kills some harmful bacteria/germs.
    • For occasional use, as needed.
  • Other Information

    • Do not store above 105 F
    • May discolor some fabrics.
  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-1003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-1003-117 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/15/2016
    Labeler - Raining Rose, Inc. (083819404)
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