Label: BOUDREAUXS- zinc oxide cream

  • NDC Code(s): 0132-0333-16, 0132-0333-22, 0132-0333-44
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 October 18, 2017

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  • Active Ingredient

    Zinc Oxide, 16%, Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protests chafed skin due to diapter 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 to prevent accidental ingestion
    • If swallowed, seek medical help or call Poison Control Center immediately
  • Directions for Use

    • Change wet and soiled diapers 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, 15C to 30C (59F to 86F)
    • Remove foil seal from the tube's tip or from jar
    • Use with infants, children and adults
    • Will stain clothing and fabric
  • Inactive Ingredients

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

  • Questions or Comments

    Phone 1-855-785-2888 website www.buttpaste.com

  • PRINCIPAL DISPLAY PANEL

    Boudreauxs Butt Paste Original Carton 4 oz

    Boudreauxs Butt Paste Original Carton 2 oz

    Boudreauxs Butt Paste Original Jar

  • INGREDIENTS AND APPEARANCE
    BOUDREAUXS 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 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:0132-0333-44113 g in 1 TUBE; Type 0: Not a Combination Product02/01/2012
    2NDC:0132-0333-2257 g in 1 TUBE; Type 0: Not a Combination Product02/01/2012
    3NDC:0132-0333-16454 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 finalpart34702/01/2012
    Labeler - C.B. Fleet Company, Inc. (003119054)
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