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Caldesene

Insight Pharmaceuticals

Caldesene Protecting Powder


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Talc 81%

Zinc Oxide 15%

Purpose

Skin Protectant

Skin Protectant

Caldesene 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

Calcium Stearate, Fragrance

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 - 71 g Label

Caldesene®

Protecting Powder
Zinc Oxide/Talc
For Babies & Adults

Treat & Prevent
Diaper Rash and
Help Protect Irritated/
Chafed Skin

TWO-WAY ACTION:

  • seals out wetness
  • protects chafed skin

Fresh Scent

NET WT 2.5 OZ (71g)

Caldesene

PRINCIPAL DISPLAY PANEL - 142 g Label

Caldesene®

Protecting Powder
Zinc Oxide/Talc
For Babies & Adults

Treat & Prevent
Diaper Rash and
Help Protect Irritated/
Chafed Skin

TWO-WAY ACTION:

  • seals out wetness
  • protects chafed skin

Fresh Scent

NET WT 5 OZ (142 g)

Caldesene

PRINCIPAL DISPLAY PANEL - 180 g Label

BONUS 25% MORE
6.25 OZ
OF POWDER FOR THE PRICE OF 5 OZ

Caldesene®

Protecting Powder
Zinc Oxide/Talc
For Babies & Adults

Treat & Prevent Diaper Rash and
Help Protect Irritated/Chafed Skin

TWO-WAY ACTION:

  • seals out wetness
  • protects chafed skin

Fresh Scent

NET WT 6.25 oz (180 g)

Caldesene

Caldesene

Talc and Zinc Oxide POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-363
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
talc 57.51 g
Zinc Oxide Zinc oxide 10.65 g

Inactive Ingredients

Ingredient Name Strength
CALCIUM STEARATE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63736-363-03 71 in 1 BOTTLE, DISPENSING
2 NDC:63736-363-05 142 in 1 BOTTLE, DISPENSING
3 NDC:63736-363-07 180 in 1 BOTTLE, DISPENSING

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2009-07-09


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