Label: BOUDREAUXS- zinc oxide ointment

  • NDC Code(s): 0132-0324-02, 0132-0324-04, 0132-0324-14
  • 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 December 3, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc oxide, 16% 

  • 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 if

    condition worsens or does not improve after 7 days

    Keep out of reach of children

    If swallowed, seek medical help or call poison control center (1-800-222-1222)

  • Directions

    • 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 15-25⁰ C (59-77⁰ F)
    • Remove foil seal from tube’s tip before use
    • For use with infants, children and adults
    • Will stain clothing and fabric
  • Inactive ingredients

    mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil

    Dist by C. B. Fleet Company, Inc.
    Tarrytown, NY 10591
    A Prestige Consumer Healthcare company
    © 2019 Trade dress is owned by C.B. Fleet company Inc. 
    All rights reserved. Made in USA

  • PRINCIPAL DISPLAY PANEL

    Sensitive Skin

    Boudreaux’s® Butt Paste

    Diaper rash ointment

    Skin protectant (16% zinc oxide)

    NET WT. 4 OZ (113 g)

    Sensitive Skin Boudreaux’s® Butt Paste Diaper rash ointment Skin protectant (16% zinc oxide) NET WT. 4 OZ (113 g)

  • INGREDIENTS AND APPEARANCE
    BOUDREAUXS 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION16 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0324-041 in 1 CARTON12/02/2019
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0132-0324-021 in 1 CARTON12/02/2019
    257 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0132-0324-14396 g in 1 JAR; Type 0: Not a Combination Product12/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34712/02/2019
    Labeler - C.B. Fleet Company, Inc. (003119054)
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