Label: BOUDREAUXS- zinc oxide paste

  • NDC Code(s): 0132-0194-14
  • 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 15, 2016

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  • Active Ingredient

    Zinc Oxide, 40%....Skin Protectant

  • Uses

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

    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 the reaach 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 tempature, 20C to 27C (68F to 80F). 
    • Remove seal from jar before use. 
    • 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

    Call 1-855-785-2888 or www.buttpaste.com

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BOUDREAUXS 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0194
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 g  in 100 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:0132-0194-14397 g in 1 JAR; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2016
    Labeler - C.B. Fleet Company, Inc. (003119054)
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