Label: CHOCTAW HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 18, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 62% v/v

  • Purpose

     Antiseptic

  • Use

    • hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.
  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

  • Warning

    For external use only

    Flammable, keep away from fire or flame.

    When using this product

    • keep out of eyes, ears, and mouth.
    • In case of eye contact immediately flush eyes thoroughly with water.

    Stop use and ask a doctor if

    • irritation or redness develops
    • conditions persist for more than 75 hours.

    Other Information:

    • Store between 15-30 ℃ (59-86℉)
    • may discolor fabrics or surfaces
  • DOSAGE & ADMINISTRATION

    • Squeeze enough product on hands to cover all surfaces
    • rub hands together until dry
    • supervise children under 6 years of age when using this product to avoid swallowing.
  • Inactive ingredients

    Water, Carbomer, Aminomethyl Propanol

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    CHOCTAW HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75255-006
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75255-006-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/18/2020
    Labeler - Guangzhou Baoli Cosmetics Co., Ltd. (526940311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Baoli Cosmetics Co., Ltd.526940311manufacture(75255-006)