Label: DNA 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 November 19, 2020

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  • Drug Facts

  • Active ingredients

    Alcohol 70% v/v

  • 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

    • On 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 thoroughly with water.

    Stop use and seek 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 15-30C (59-86F).
    • Avoid freezing and excessive heat above 40C (104F).
  • Inactive ingredients

    Water, Carbomer, Glycerin, Triethanolamine, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

  • Questions?

    call 888 387 3887

  • Company Information

    Distributed by:

    Welburn Corporation

    Hermosa Beach, CA 90254

    Made in Guatemala

  • Product Packaging - 500 ML

    ADVANCED FORMULA

    DNA

    HAND

    SANITIZER

    GEL

    70% SUGAR CANE ALCOHOL

    NON STERILE SOLUTION

    WITH MOISTURIZING INGREDIENTS

    16.9 FL. OZ. / 500 ML

    dna hand sanitizer

  • INGREDIENTS AND APPEARANCE
    DNA HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77622-031
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77622-031-03236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
    2NDC:77622-031-10500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
    3NDC:77622-031-083785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
    4NDC:77622-031-02119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/19/2020
    Labeler - Welburn Corporation (117515830)
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