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
  • Marketing Status: OTC monograph 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 March 1, 2021

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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

    MAX STRENGTH
    EXTRA PROTECTION*
    BOUDREAUX’S
    BUTT PASTE

    NET WT. 2 OZ (57 g)

    PRINCIPAL DISPLAY PANEL MAX STRENGTH EXTRA PROTECTION* BOUDREAUX’S BUTT PASTE NET WT. 2 OZ (57 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:0132-0323-14397 g in 1 JAR; 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:0132-0323-44113 g in 1 TUBE; Type 0: Not a Combination Product02/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34702/01/2012
    Labeler - C.B. Fleet Company, Inc. (003119054)
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