Label: CALDESENE BABY- starch, corn and zinc oxide powder

  • NDC Code(s): 63736-305-05
  • Packager: Insight Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 29, 2024

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  • SPL UNCLASSIFIED SECTION

    Caldesene® 
    Baby

    Drug Facts

  • Active ingredients

    Cornstarch 81%

    Zinc Oxide 15%

  • Purpose

    Skin Protectant

    Skin Protectant

  • Uses

    • helps treats and prevents diaper rash
    • temporarily protects and helps relieve minor skin irritation
  • Warnings

    For external use only.

    Do not use

    on broken skin.

    When using this product

    • do not get into 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. Apply as needed.
  • Other information

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

    aloe vera gel, chamomile, fragrance, kaolin, tricalcium phosphate

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 142 g Label

    Caldesene® 
    Baby

    Skin Protectant / Cornstarch Powder 18%
    and Zinc Oxide 15%

    NET WT 5 OZ (142 g)

    PRINCIPAL DISPLAY PANEL - 142 g Label Caldesene® Baby Skin Protectant / Cornstarch Powder 18% and Zinc Oxide 15% 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 DrugM01607/07/2009
    Labeler - Insight Pharmaceuticals LLC (055665422)
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