Label: 70% ALCOHOL HAND SANITZER- 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 June 25, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • When using this product

    Avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

  • Stop use and ask a doctor if

    irritation or redness develops

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center.

  • Directions

    • Wet hands thoroughly with product and rub into skin until dry.
    • Children under 6 years of age should be supervised by an adult when using.
  • Other information

    • Store at room temperature
    • May discolor certain fabrics
  • Inactive ingredients

    Deionized Water, Glycerol, Carbopol, Triethanolamine

  • Package Label - Principal Display Panel

    60 mL NDC: 75021-003-01

    PDP

  • INGREDIENTS AND APPEARANCE
    70% ALCOHOL HAND SANITZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75021-003(NDC:56084-020)
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75021-003-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/18/2020
    Labeler - D Zone Imports, Llc (604227103)
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