Label: KERMA 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 January 25, 2022

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  • Active lngredient  

    Ethyl Alcohol

  • Purpose 

    Antiseptic 

  • Uses 

    Hand sanitizer to help reduce bacteria that potentially can cause disease. 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 this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Place 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

  • Other information

    Store between 15-30°C (59-86F)

    Avoid freezing and excessive heat above 40°C (104F)

  • Inactive Ingredients

    Water, Fragrance, Carbomer, PEG-40 Hydrogenated Castor Oil, chlorphenesin, Aminomethyl Propanol

  • KEEP OUT OF REACH OF CHILDREN

  • product Label

    image description

  • INGREDIENTS AND APPEARANCE
    KERMA HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71358-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71358-018-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/03/2020
    Labeler - MCCORD RESEARCH (010011284)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wasatch Product Development, LLC962452533manufacture(71358-018)