Label: ANTISEPTIC HAND SANITIZER- isopropyl 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 May 4, 2020

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  • Drug Facts

  • Active ingredient

    Isopropyl alcohol 70%

    Purpose

    Antiseptic

  • Uses

    • for hand washing to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only
    Flammable, keep away from fire or flame.

    Do not use

    in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    wet hands thoroughly with product and allow to dry without wiping

  • Inactive ingredients

    carbomer, imidazolidinyl urea, PEG-12 dimethicone, propylene chlorhexidine gluconate, triethanolamine, water

  • Questions or Comments?

    +1 (888) 408-1694

  • Package Labeling:

    Outer PackageInner PackageBox

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74785-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    IMIDUREA (UNII: M629807ATL)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74785-000-00250 in 1 BOX05/01/2020
    11.5 mL in 1 DOSE PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - V-Shapes Srl (438846579)
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