Label: SIERRA SOFT NON-ALCOHOL FOAM HAND SANITIZER- benzalkonium chloride solution

  • NDC Code(s): 70415-106-11, 70415-106-21
  • 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 hand washing to reduce bacteria on the skin. Recommended for repeat use.
  • Warnings

    For external use only.

    Avoid contact with eyes - in case of contact, flush eyes with water.

    Keep out of reach of children. If swallowed, get immediate medical attention.

  • STOP USE

    Stop use and ask doctor if irritation or redness develops and persists.

  • Directions

    Apply foam sanitizer to hands. Rub over surfaces of both hands for 15 seconds. No rinsing required.

  • Inactive ingredients

    Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Label1083-05NonAlcoholFoamSanizerPLTCC104-040119

  • INGREDIENTS AND APPEARANCE
    SIERRA SOFT NON-ALCOHOL FOAM HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70415-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70415-106-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2016
    2NDC:70415-106-2118925 mL in 1 PAIL; Type 0: Not a Combination Product10/04/2017
    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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