BABYS BUTT AID (ZINC OXIDE) OINTMENT [GREENBRIER INTERNATIONAL INC]

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BABYS BUTT AID (ZINC OXIDE) OINTMENT [GREENBRIER INTERNATIONAL INC]
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NDC 33992-1306-1
Set ID 349d27e8-df53-4d4f-8833-b249e948acee
Category HUMAN OTC DRUG LABEL
Packager GREENBRIER INTERNATIONAL INC
Generic Name
Product Class
Product Number
Application Number PART352
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  • 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)
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