Label: STERIL-WIZE ANTI-BACTERIAL FOAMING HAND- benzalkonium chloride soap

  • Category: HUMAN OTC DRUG LABEL

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 July 6, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride .13%

    Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin.
  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. In case of eye contact, flush eyes with water. Do not ingest.

    Stop use and ask a doctor

    If irritation or redness develops and conditions persist.

    Keep out of reach of children.

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

  • Directions

    • Apply soap into hands, wet as needed 
    • Lather vigorously for at least 15 seconds · Wash skin, rinse thoroughly and dry.
  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, Glycerine, Caprylyl Glucoside, Tetrasodium EDTA, Benzisothiazol, Methylisothiazol, Fragrance, Citric Acid, Aloe Vera, Yellow #5, Red #40.

  • Package Labeling:946.35 mL

    Bottle

  • Package Labeling:3.785L

    Bottle2

  • INGREDIENTS AND APPEARANCE
    STERIL-WIZE ANTI-BACTERIAL FOAMING HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77051-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77051-001-32946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    2NDC:77051-001-373785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/16/2020
    Labeler - Nostalgia Products LLC (080132557)
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