Label: BOUDREAUXS- zinc oxide cream

  • NDC Code(s): 0132-0323-14, 0132-0323-22, 0132-0323-44
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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  • SPL UNCLASSIFIED SECTION

  • BOUDREAUXS- zinc oxide cream

    C.B. Fleet Company, Inc.

    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.

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    Drug Facts

  • Active Ingredient

    Zinc Oxide, 40%

  • Purpose

    Skin Protectant

  • Uses

    Helps treat and prevent diaper rash

    Protects chafed skin due to diaper rash and helps seal out wetness

  • Warnings

    For external use only

    When using this product avoid contact with the eyes

  • Stop use and ask a doctor

    Stop use and ask a doctor if condition worsens or does not improve after 7 days

  • Keep out of reach of children

    Keep out of reach of children to prevent accidental ingestion

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

  • 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

  • Other Information

    Store at room temperature, 20C to 27C (68F to 80F) Remove foil seal from the tube's tip

    Use with infants, children and adults Will stain clothing and fabric

  • Inactive Ingredients

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

  • Questions or Comments

    Call toll free 1-855-785-2888

    website www.buttpaste.com

  • PRINCIPAL DISPLAY PANEL

    TREATS & PROTECTS
    BOUDREAUX’S
    BUTT PASTE
    MAX STRENGTH
    NET WT. 2 OZ (57 g)

    TREATS & PROTECTS BOUDREAUX’S BUTT PASTE MAX STRENGTH NET WT. 2 OZ (57 g)

  • PRINCIPAL DISPLAY PANEL

    BOUDREAUX’S
    BUTT PASTE
    Zinc oxide 40%
    MAX STRENGTH
    NET WT. 14 OZ (396 g)

    BOUDREAUX’S BUTT PASTE Zinc oxide 40% MAX STRENGTH NET WT. 14 OZ (396 g)

  • INGREDIENTS AND APPEARANCE
    BOUDREAUXS 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0323
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0323-44113 g in 1 TUBE; Type 0: Not a Combination Product02/01/2012
    2NDC:0132-0323-2257 g in 1 TUBE; Type 0: Not a Combination Product02/01/2012
    3NDC:0132-0323-14397 g in 1 JAR; Type 0: Not a Combination Product02/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/01/2012
    Labeler - C.B. Fleet Company, Inc. (003119054)
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