Caldesene Medicated Protecting Powder

Caldesene Medicated Protecting Powder
SPL v5
SPL
SPL Set ID ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b
Route
TOPICAL
Published
Effective Date 2024-01-26
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 2017-07-15

Description

Drug Facts

Purpose

Skin Protectant Skin Protectant


Medication Information

Purpose

Skin Protectant

Skin Protectant

Description

Drug Facts

Uses
  • helps treat and prevents diaper rash

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

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 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

Principal Display Panel

Caldesene ®

by Boudreaux’s Butt Paste ®

Medicated Protecting Powder

Skin protectant / cornstarch 81%

and zinc oxide 15%







NET WT 5 OZ (142 g)

When Using This Product
  • avoid contact with eyes

  • keep away from 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.


Structured Label Content

Uses
  • helps treat and prevents diaper rash

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

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 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Caldesene ®

by Boudreaux’s Butt Paste ®

Medicated Protecting Powder

Skin protectant / cornstarch 81%

and zinc oxide 15%







NET WT 5 OZ (142 g)

When Using This Product (When using this product)
  • avoid contact with eyes

  • keep away from 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.


Advanced Ingredient Data


Raw Label Data

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