Label: 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 30, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 62% 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

    When using this product avoid contact with face, eyes, and broken skin. If eyes contact occurs, flush thoroughly with water and seek medical advice.

    Stop use and ask a doctor if irritation or rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hand thoroughly with product and rub into skin until dry.
    • Children under 6 years of age should be supervised by an adult when using this product.
  • Inactive ingredients

    aqua (water, eau), propylene glycol, glycerin, carbomer, aminomethyl propanol, isopropyl myristate, t-butyl alcohol

  • Package Label - Principal Display Panel

    dial pdp221 mL NDC: 61531-389-01

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61531-389
    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
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
    2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL (UNII: SJ211700DZ) 0.5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61531-389-01221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - PakLab (790530976)
    Registrant - PakLab (790530976)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab790530976manufacture(61531-389) , label(61531-389) , pack(61531-389)
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