Label: MODESA MOISTURIZING HAND ANTIBACTERIAL- benzethonium chloride liquid

  • 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 December 26, 2017

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  • 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

    ■ apply onto wet hands, lather and rinse thoroughly

  • Inactive ingredients

    water, lauramine oxide, cetrimonium chloride, cocamidopropylamine oxide, cocamide MEA, glycerin, PEG-150 distearate, sodium chloride, fragrance, citric acid, sodium benzoate, tetrasodium EDTA, FD&C blue no.1, D&C red no.33

  • Package Label

    Package label

  • INGREDIENTS AND APPEARANCE
    MODESA  MOISTURIZING HAND ANTIBACTERIAL
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-431
    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
    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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-431-75221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/18/2017
    2NDC:55319-431-401180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/18/2017
    Labeler - Family Dollar Services Inc. (024472631)
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