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Caldesene Baby

Dosage form: powder
Ingredients: Starch, Corn 115g in 142g, Zinc Oxide 21g in 142g
Labeler: Insight Pharmaceuticals
NDC Code: 63736-305

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 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

Product packaged by weight not volume.

Store at room temperature 15°–25°C (59°–77°F).

QUESTIONS

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

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)

CALDESENE BABY 
starch, corn and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-305
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Starch, Corn (Starch, Corn) Starch, Corn115 g  in 142 g
Zinc Oxide (Zinc Oxide) Zinc Oxide21 g  in 142 g
Inactive Ingredients
Ingredient NameStrength
Kaolin 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63736-305-05142 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34707/07/2009
Labeler - Insight Pharmaceuticals (176792315)

Revised: 09/2009
 
Insight Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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