CALDESENE BABY (STARCH, CORN AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS LLC]

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CALDESENE BABY (STARCH, CORN AND ZINC OXIDE) POWDER [INSIGHT PHARMACEUTICALS LLC]
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NDC 63736-305-05
Set ID 9f12dee2-7afa-45e9-a729-0fd42bb77715
Category HUMAN OTC DRUG LABEL
Packager Insight Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Caldesene® 
    Baby

    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
    • keep away from child's face and mouth to avoid breathing it

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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
  • Other information

    Store at room temperature 15°–25°C (59°–77°F). See container for lot number and expiration date.

  • Inactive ingredients

    aloe vera, chamomile, fragrance, kaolin, tricalcium phosphate

  • Questions?

    1-800-344-7239 www.caldesene.com

    Product packaged by weight not volume.

  • PRINCIPAL DISPLAY PANEL - 142 g Label

    Caldesene® 
    Baby

    Cornstarch Powder
    with Zinc Oxide

    NET WT 5 OZ (142 g)

    PRINCIPAL DISPLAY PANEL - 142 g Label Caldesene® Baby Cornstarch Powder with Zinc Oxide NET WT 5 OZ (142 g)

  • INGREDIENTS AND APPEARANCE
    CALDESENE BABY 
    starch, corn and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STARCH, CORN (UNII: O8232NY3SJ) (STARCH, CORN - UNII:O8232NY3SJ) STARCH, CORN115 g  in 142 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 142 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    KAOLIN (UNII: 24H4NWX5CO)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-305-05142 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/07/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34707/07/2009
    Labeler - Insight Pharmaceuticals LLC (055665422)
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