FDA Label for Caldesene Baby

View Indications, Usage & Precautions

Caldesene Baby Product Label

The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)


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