Label: HAND SANITIZER- 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 7, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use


    Hand sanitizing to reduce bacteria on skin. No rinsing required. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING


    When using this product. Not for internal use, do not swallow or inhale. If swallowed, do not induce vomiting. Consult a physician or a Poison Control Center immediately. Keep out of eyes. In case of thoroughly with cold water. Avoid contact with broken skin.

  • STOP USE


    Stop use and ask doctor if irritation or rash persists for more than 24 hours. These may be signs of a serious condition. Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children and pets. Children must be supervised when using this product

  • Directions

    • Put enough product in your palm to cover hands. Rub hands together until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
    • May discolor some fabrics. Harmful to wood finishes and plastics.
    • Dispose in accordance wiht all applicable federal, state and local regulations
  • Inactive ingredients


    Water (Aqua), Acrylates/C10-30 alkyl acrylate crosspolymer, Aloe barbadensis leaf extract, Triethanolamine

  • Package Label - Principal Display Panel

    50 mL NDC:65657-071-01 Front labelsback labels

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65657-071
    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
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65657-071-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/07/2020
    Labeler - Chico's FAS INC (114332232)
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