Label: SIERRA SOFT NON-ALCOHOL FOAM SANITIZER- benzalkonium chloride gel

  • NDC Code(s): 70415-103-11, 70415-103-12
  • Packager: CWGC LA Inc.
  • 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 September 21, 2023

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  • Active ingredient

    BENZALKONIUM CHLORIDE 0.13%

    Purpose

    Antibacterial

  • Uses

    • For sanitizing to reduce bacteria on the skin.
  • Warnings

    For external use only

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

  • Directions

    TO USE, SIMPLY PLACE CARTRIDGE INTO DISPENSER AND USE STRAIGHT; DO NOT DILUTE. APPLY 1 PUMP OF SANITIZER ONTO HANDS AND RUB INTO SKIN. NO RINSING REQUIRED.

  • Inactive ingredients

    Water, Propylene Glycol, Cocamidopropyl Betaine, Cocamine Oxide, Disodium EDTA, DMDM Hydantoin, Triethanolamine, Fragrance, FD&C Yellow No.5, FD&C Blue No.1.

  • PRINCIPAL DISPLAY PANEL

    Sierra Soft_Non-Alcohol Foam Sanitizer_SL_1L

    Sierra Soft_Non-Alcohol Foam Sanitizer_SL_42oz

  • INGREDIENTS AND APPEARANCE
    SIERRA SOFT NON-ALCOHOL FOAM SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70415-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70415-103-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2016
    2NDC:70415-103-121250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/04/2016
    Labeler - CWGC LA Inc. (034967904)
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