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Caldesene Baby

Medically reviewed on May 14, 2018

Dosage form: powder
Ingredients: STARCH, CORN 115g in 142g, ZINC OXIDE 21g in 142g
Labeler: Insight Pharmaceuticals LLC
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 Powder

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

© 2016 Distributed by: Insight Pharmaceuticals LLC. 
Tarrytown, NY 10591

A Prestige Brands Company

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)

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
ALOE VERA LEAF 
CHAMOMILE 
KAOLIN 
TRICALCIUM PHOSPHATE 
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 FINALpart34707/07/2009
Labeler - Insight Pharmaceuticals LLC (055665422)

 
Insight Pharmaceuticals LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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