Label: BOUDREAUXS- zinc oxide cream 

  • NDC Code(s): 0132-0323-44
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • Active Ingredient

    Zinc Oxide, 40%........Skin Protectant

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  • Warnings

    • For external use only
    • When using this product avoid contact with the eyes
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  • Stop use and ask a doctor if

    Condition worsens or does not improve after 7 days

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  • Warnings

    Keep out of the reach of children

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  • Warnings

    If swallowed, seek medical help or call Poison Control Center immediately

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  • Inactive Ingredients

    Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, Petrolatum

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  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash and helps seal out wetness
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  • Other Information

    • Store at room temperature, 20C to 27C (68F to 80F)
    • Use with infants, children and adults
    • Will stain clothing and fabric
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  • Directions for Use

    • Change wet and soiled diaper immediately
    • Cleanse the diaper area and allow to dry
    • Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime
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  • Questions?

    Call toll free 1-855-785-2888

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  • INGREDIENTS AND APPEARANCE
    BOUDREAUXS 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0132-0323
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 40 g  in 113 g
    Inactive Ingredients
    Ingredient Name Strength
    CASTOR OIL  
    MINERAL OIL  
    PARAFFIN  
    BALSAM PERU  
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0132-0323-44 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 02/01/2012
    Labeler - C.B. Fleet Company, Inc. (003119054)
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