Label: BOOTY GOO- 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 May 14, 2013

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  • Active Ingredient

    Drug Facts

    Active Ingredient

    Zinc Oxide 25%

  • Purpose

    Skin Protectant

  • Keep out of reach of children

    Keep out of reach of children.

  • Uses

    • Helps soothe, treat , and prevent diaper rash
    • Repels wetness
    • Protects delicate skin
    • Relieves chapped, moist or irritated areas
    • Prevents Friction
  • Warnings

    For external use only.

    When using this product, do not get into eyes.

    Stop and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use on deep puncture wounds, animal bites, serious burns.

    If swallowed, get medical help or contact a Poison control Center right away.


  • Directions

    Cleanse and dry diaper area. Apply liberally as often as necessary, with each diaper change at least 3 or 4 times a day, definitely at bedtime when wet diapers may be prolonged. Store between 15° - 30° C, (59° - 86° F)

  • Inactive ingredients

    Peruvian Balsam, Vitamin E (Tocopherol), Aloe, Acidum Boricum, White Petrolatum, Mineral Oil, Castor Oil, Microcrystalline Wax, White Beeswax.

  • Product Label

    NDC # 434479440-1

    Pharmacist Formulated  Pediatrician Recommended

    Booty®Goo

    DIAPER CHANGE OINTMENT

    Soothes, treats and prevents Diaper Rash

    Frangrance Free
    Repels Wetness
    Natural Ingredients for Healthy Skin
    Non-Greasey, Non-Staining

    Net Wt 2.5 oz (71g)

    VISIBLE IMPROVEMENT WITHIN 24 HRS

    Manufactured by:

    SKIN SAKE, LLC

    P.O. Box 390, Hamburg, AT 71646

    1-888-853-5544  bootygoo.com

    2101944-03

    SS Booty Goo1 Label


  • INGREDIENTS AND APPEARANCE
    BOOTY GOO 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43447-9440
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.75 g  in 71 g
    Inactive Ingredients
    Ingredient NameStrength
    BALSAM PERU (UNII: 8P5F881OCY)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE (UNII: V5VD430YW9)  
    BORIC ACID (UNII: R57ZHV85D4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43447-9440-171 g in 1 TUBE
    2NDC:43447-9440-0100 in 1 BOX
    2NDC:43447-9440-22 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/01/2005
    Labeler - Skin Sake, LLC (195912717)
    Registrant - Skin Sake, LLC (195912717)
    Establishment
    NameAddressID/FEIBusiness Operations
    Memphis Contract Packaging, Inc.185390010manufacture(43447-9440)
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