Label: BOUDREAUXS- zinc oxide cream

  • NDC Code(s): 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 September 15, 2017

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Zinc Oxide, 40%, Skin Protectant

    Close
  • Uses

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

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

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

    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • Inactive Ingredients

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

    Close
  • Questions or Comments

    Call toll free 1-855-785-2888

    website www.buttpaste.com

    Close
  • INGREDIENTS AND APPEARANCE
    BOUDREAUXS 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0323
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 40 g  in 113 g
    Inactive Ingredients
    Ingredient Name Strength
    CASTOR OIL (UNII: D5340Y2I9G)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0132-0323-44 113 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2012
    2 NDC:0132-0323-22 57 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 02/01/2012
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    Name Address ID/FEI Business Operations
    Applied Laboratories, Inc. 117337220 manufacture(0132-0323)
    Close