Label: HAND 2 HAND SANITIZER- isopropyl alcohol 70% 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 14, 2021

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  • Active Ingredient

    Isopropyl Alcohol 70%

  • 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

    Do not use with children less than 2 months of age. On open wounds or broken skin.

  • 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

    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 15-30C (59-86F). -Avoid freezing and temperatures above 40C (104F).

  • Inactive Ingredients

    Water (Aqua), Carbomer, Glycerin, Trolamine

  • Hand 2 Hand Sanitizer

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  • INGREDIENTS AND APPEARANCE
    HAND 2 HAND SANITIZER 
    isopropyl alcohol 70% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78437-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL42 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78437-100-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC:78437-100-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    3NDC:78437-100-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    4NDC:78437-100-373785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    5NDC:78437-100-641892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - ASI Chemical, Inc. (069824840)
    Registrant - ASI Chemical, Inc. (069824840)
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