FAMILY DOLLAR ANTIBACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [FAMILY DOLLAR SERVICES INC.]

FAMILY DOLLAR ANTIBACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [FAMILY DOLLAR SERVICES INC.]
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NDC 55319-430-40, 55319-430-75
Set ID 3fc6bb6f-ada5-0e89-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient

    Benzethonium chloride 0.10%

  • Purpose

    Antibacterial

  • Use

    for hand washing to decrease bacteria on the skin

  • Warnings

    For external use only

  • When using this product

    ■ avoid contact with the eyes. In case of eye contact, flush with water.

  • Stop use and ask a doctor if


    ■ irritation and redness develops

  • Keep out of reach of children

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

  • Directions

    ■ pump into hands, wet as needed ■ lather vigorously for at least 15 seconds ■ wash skin, rinse thoroughly and dry

  • Inactive ingredients

    water, lauramine oxide, cetrimonium chloride, cocamidopropylamine oxide, cocamide MEA, glycerin, PEG-150 distearate, sodium chloride, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, FDC yellow no.5, DC red no.33, FDC yellow no.6

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    FAMILY DOLLAR  ANTIBACTERIAL
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-430
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-430-75221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/19/2016
    2NDC:55319-430-401180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/19/2016
    Labeler - Family Dollar Services Inc. (024472631)

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