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Caldesene Baby (Insight Pharmaceuticals)

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POWDER 142 g in 1 BOTTLE, DISPENSING (63736-305-05) Label Information

Complete Caldesene Baby Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredients

    Cornstarch 81%

    Zinc Oxide 15%


  • Purpose

    Skin Protectant

    Skin Protectant


  • Uses

    • treats and prevents diaper rash
    • protects minor skin irritation

  • Warnings

    For external use only

    Do not use
    • on broken skin

    When using this product
    • avoid contact with eyes and face
    • keep powder away from child's face to avoid inhalation, which can cause breathing problems

    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

    For diaper rash

    • change wet or soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply powder liberally, as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged
    • apply powder close to the body away from child's face
    • carefully shake the powder into the diaper or into the hand and apply to diaper area

    For minor skin irritations

    • smooth on powder to protect irritated and chafed skin

  • Inactive ingredients

    Aloe Vera, Chamomile, Fragrance, Kaolin and Tricalcium Phosphate


  • STORAGE AND HANDLING

    Product packaged by weight not volume.

    Store at room temperature 15°â€“25°C (59°â€“77°F).


  • QUESTIONS

    Call 1-800-344-7239
    or visit our website at www.insightpharma.com


  • SPL UNCLASSIFIED SECTION

    Distributed by: INSIGHT Pharmaceuticals Corp.
    Langhorne, PA 19047-1749


  • PRINCIPAL DISPLAY PANEL - 142 g Label

    Caldesene®
    Baby

    Cornstarch Powder
    with Zinc Oxide

    Plus Skin-Soothing
    Aloe and Chamomile

    Helps Treat & Prevent
    Diaper Rash

    Helps Protect Against
    Irritated/Chafed Skin

    NET WT 5 oz (142 g)

    Principal Display Panel - 142 g Label

  • INGREDIENTS AND APPEARANCE
    CALDESENE BABY 
    starch, corn and zinc oxide powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-305
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Starch, Corn (UNII: O8232NY3SJ) (Starch, Corn - UNII:O8232NY3SJ) Starch, Corn 115 g  in 142 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 21 g  in 142 g
    Inactive Ingredients
    Ingredient Name Strength
    Kaolin (UNII: 24H4NWX5CO)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63736-305-05 142 g in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 07/07/2009
    Labeler - Insight Pharmaceuticals (176792315)