Diaper Rash Cream

Diaper Rash Cream
SPL v1
SPL
SPL Set ID 01cc78d6-7948-97c4-e063-6394a90a1708
Route
TOPICAL
Published
Effective Date 2023-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (400 mg)
Inactive Ingredients
Sunflower Oil Polyhydroxystearic Acid Stearate Starch, Corn Calophyllum Tacamahaca Seed Oil Castor Oil Shea Butter Tocopherol Cocoa Butter Helianthus Annuus Seed Wax Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-13

Description

Zinc Oxide - 40%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide - 40%

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Section 51945-4

Warnings

For external use only

Directions
  • Change wet and soiled diapers promptly.
  • Cleanse the diaper area and allow to dry.
  • Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
  • Do not use if quality seal is broken
  • Do not store above 40C (104F)
Active Ingredients

Zinc Oxide - 40%

Inactive Ingredients

Helianthus Annus (Sunflower) Seed Oil*, Ricinus Communis (Castor) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Polyhydroxystearic Acid, Helianthus Anuus (Sunflower) Seed Wax*, Cocos Nucifera (Coconut) Oil*, Theobroma Cacao (Cocoa) Seed Butter*, Colophyllum Tacamahaca Seed Oil*, Tocopherol*, Zea Mays (Corn) Starch*

*Organic

When Using This Product,

do not get into eyes

Stop Use and Ask A Doctor

if condition worsens or 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 right away


Structured Label Content

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

For external use only

Directions
  • Change wet and soiled diapers promptly.
  • Cleanse the diaper area and allow to dry.
  • Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
  • Do not use if quality seal is broken
  • Do not store above 40C (104F)
Active Ingredients

Zinc Oxide - 40%

Inactive Ingredients

Helianthus Annus (Sunflower) Seed Oil*, Ricinus Communis (Castor) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Polyhydroxystearic Acid, Helianthus Anuus (Sunflower) Seed Wax*, Cocos Nucifera (Coconut) Oil*, Theobroma Cacao (Cocoa) Seed Butter*, Colophyllum Tacamahaca Seed Oil*, Tocopherol*, Zea Mays (Corn) Starch*

*Organic

When Using This Product, (When using this product,)

do not get into eyes

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if condition worsens or 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 right away


Advanced Ingredient Data


Raw Label Data

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