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BABYS BUTT AID (HANGZHOU MINO DAILY CHEMICALS CO.LTD.)

Available Formats

Dosage Form Package Information Links
OINTMENT 59 mL in 1 TUBE (35038-100-20) Label Information

Complete BABYS BUTT AID Information

  • Warnings

    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.


  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:35038-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 16 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BORIC ACID (UNII: R57ZHV85D4) 2 mL  in 100 mL
    CASTOR OIL (UNII: D5340Y2I9G) 30 mL  in 100 mL
    MINERAL OIL (UNII: T5L8T28FGP) 31.5 mL  in 100 mL
    PARAFFIN (UNII: I9O0E3H2ZE) 10 mL  in 100 mL
    PETROLATUM (UNII: 4T6H12BN9U) 10 mL  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35038-100-20 59 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 03/01/2011
    Labeler - HANGZHOU MINO DAILY CHEMICALS CO.LTD. (527974203)
    Establishment
    Name Address ID/FEI Business Operations
    HANGZHOU MINO DAILY CHEMICALS CO.LTD. 527974203 manufacture