Label: BABYS BUTT AID- zinc oxide ointment

  • 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 10, 2021

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  • Active Ingredient

    Active ingredient

    Zinc Oxide 16%

  • Purpose

    Purpose

    Skin Protectant

  • Uses

    Uses • Helps treat and prevent diaper rash • Prevents chafed skin due to diaper rash and helps seal out wetness.

  • Warnings

    Warnings

    For external use only.

  • When using this product

    When using this product, avoid contact with eyes.

  • Stop use and ask a doctor

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

  • Keep out of reach of children


    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions: • Change wet and soiled diapers promptly. • Cleanse the diaper area and allow to dry. • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

  • Other information

    Other information: store at 20° to 27°C (68° to 80.6°F)

  • Inactive ingredients

    Inactive ingredients: petrolatum, mineral oil, hydroxyethyl cellulose, pentaerythrityl tetrastearate, microcrystalline wax, propylparaben, fragrance.

  • Distributed By:

    Distributed By: American Consumer Products Corp

    Vernon, CA 90058

    MADE IN CHINA

  • Package Label

    Babys Butt AidBabys Butt Aid

  • INGREDIENTS AND APPEARANCE
    BABYS BUTT AID 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72197-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PENTAERYTHRITYL TETRASTEARATE (UNII: W9Q3DZS0EG)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite ((Beige)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72197-039-0256 g in 1 TUBE; Type 0: Not a Combination Product01/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/20/2021
    Labeler - American Consumer Products Corp (081101181)
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