Label: HAND SANITIZER 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 April 16, 2021

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • INACTIVE INGREDIENT

    Water (aqua), propylene glycol, phenoxyethanol,fragrance (parfum), hydroxyethylcellulose, alcohol linalool, limonene, citronellol, citral.

  • Directions

    Place enough product on hands to cover all surfaces.Rub hands together until dry.

  • WARNINGS

    For external use only.

  • DO NOT USE

    Do not use on open skin wounds or children under 2 months of age.

  • WHEN USING

    When using this product keep out of eyes,ears, and mouth. ln case of contact with eyes,rinse eyes thoroughly with water.

  • STOP USE

    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

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

  • Other information

    Store in a cool dry place, away from direct sunlight and heat.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81726-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1235 g  in 95 mL
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE EUCALYPTUS SPEARMINT ORC1601627 (UNII: E90O5M6HMB)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81726-005-0195 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/12/2021
    Labeler - The Source Design Collections (527929622)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Source Design Collections527929622manufacture(81726-005)
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