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 a 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 and pets. Children must be supervised when using this product.

  • Directions

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

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

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

  • Package Label - Principal Display Panel

    Front labellabel50 mL NDC: 65657-070-01

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65657-070
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65657-070-0150 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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