Caldesene Baby Powder 636736-305

Caldesene Baby Powder 636736-305
SPL v5
SPL
SPL Set ID 9f12dee2-7afa-45e9-a729-0fd42bb77715
Route
TOPICAL
Published
Effective Date 2024-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Starch, Corn (115 g) Zinc Oxide (21 g)
Inactive Ingredients
Aloe Vera Leaf Chamomile Kaolin Tricalcium Phosphate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-07-07

Description

Caldesene®  Baby Drug Facts

Purpose

Skin Protectant Skin Protectant


Medication Information

Purpose

Skin Protectant

Skin Protectant

Description

Caldesene®  Baby Drug Facts

Uses
  • helps treats and prevents diaper rash

  • temporarily protects and helps relieve minor skin irritation
Section 42229-5

Caldesene® 

Baby

Drug Facts

Warnings

For external use only .

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. Apply as needed.
Do Not Use

on broken skin.

Questions?

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

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

  • See container bottom for lot number and expiration date.
Active Ingredients

Cornstarch 81%

Zinc Oxide 15%

Inactive Ingredients

aloe vera gel, chamomile, fragrance, kaolin, tricalcium phosphate

When Using This Product
  • do not get into 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.

Principal Display Panel 142 G Label

Caldesene ®  

Baby

Skin Protectant / Cornstarch Powder 18%

and   Zinc Oxide 15%

NET WT 5 OZ (142 g)


Structured Label Content

Uses
  • helps treats and prevents diaper rash

  • temporarily protects and helps relieve minor skin irritation
Section 42229-5 (42229-5)

Caldesene® 

Baby

Drug Facts

Purpose

Skin Protectant

Skin Protectant

Warnings

For external use only .

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. Apply as needed.
Do Not Use (Do not use)

on broken skin.

Questions?

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

Other Information (Other information)
  • Store at room temperature 15°–25°C (59°–77°F). 

  • See container bottom for lot number and expiration date.
Active Ingredients (Active ingredients)

Cornstarch 81%

Zinc Oxide 15%

Inactive Ingredients (Inactive ingredients)

aloe vera gel, chamomile, fragrance, kaolin, tricalcium phosphate

When Using This Product (When using this product)
  • do not get into eyes

  • keep away from child's face and mouth to avoid breathing it
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Principal Display Panel 142 G Label (PRINCIPAL DISPLAY PANEL - 142 g Label)

Caldesene ®  

Baby

Skin Protectant / Cornstarch Powder 18%

and   Zinc Oxide 15%

NET WT 5 OZ (142 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)