CALDESENE BABY- starch, corn and zinc oxide powder

Caldesene Baby by

Drug Labeling and Warnings

Caldesene Baby by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

CALDESENE BABY 
starch, corn and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STARCH, CORN (UNII: O8232NY3SJ) (STARCH, CORN - UNII:O8232NY3SJ)	STARCH, CORN	115 g  in 142 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21 g  in 142 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
KAOLIN (UNII: 24H4NWX5CO)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-305-05	142 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/07/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	07/07/2009

Labeler - Insight Pharmaceuticals LLC (055665422)