Label: BABYS BUTT AID- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 1, 2014

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

View All Sections
  • DRUG FACTS

    For external use only

    • flammable, keep away from fire and flame
    • will produce serious gastric disturbances if taken internally

    Ask a doctor before use if you have deep puncture wounds or serious burns

    When using this product

    • do not get into eyes or mucous membranes
    • use only in a well-ventilated area

    Stop use and ask a doctor if condition persists or gets worse.

    Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

  • Active ingredient

    Zinc Oxide 16%

  • Purpose

    Skin Protectant

  • 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, avoid contact with eyes.

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

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

  • 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

    store at 20 to 27 C (68 to 80.6 F)

  • Inactive ingredients

    boric acid, castor oil, microcrystalline wax, mineral oil, paraffin, peruvian balsam, petrolatum

  • PRINCIPAL DISPLAY PANEL

    Baby Butt Aid LabelEnter section text here

  • INGREDIENTS AND APPEARANCE
    BABYS BUTT AID 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1306
    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
    BORIC ACID (UNII: R57ZHV85D4) 2 g  in 100 g
    CASTOR OIL (UNII: D5340Y2I9G) 30 g  in 100 g
    MINERAL OIL (UNII: T5L8T28FGP) 31.5 g  in 100 g
    PARAFFIN (UNII: I9O0E3H2ZE) 10 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) 10 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-1306-11 in 1 BOX
    156 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2011
    Labeler - GREENBRIER INTERNATIONAL INC (610322518)
    Registrant - HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED (547695235)
    Establishment
    NameAddressID/FEIBusiness Operations
    HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED547695235manufacture(33992-1306)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!