Zinc Oxide 40% Diaper Rash Cream

Zinc Oxide 40% Diaper Rash Cream
SPL v1
SPL
SPL Set ID e9201a26-46b3-477f-e053-2995a90a5e0e
Route
TOPICAL
Published
Effective Date 2022-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (40 g)
Inactive Ingredients
Coconut Oil Shea Butter Cocoa Butter Calophyllum Tacamahaca Seed Oil Starch, Corn Sunflower Oil Polyhydroxystearic Acid (2300 Mw) Castor Oil Helianthus Annuus Seed Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-09-20
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
Label

Section 50565-1

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

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredient

Zinc oxide 40%

Other Information
  • See box for more details
Inactive Ingredients

Sunflower oil, Castor Oil, Sunflower seed wax, polyhydroxystearic acid, shea butter, coconut oil, theobroma cacao seed butter, calophyllum seed oil, tocopherol, zea mays corn starch

Questions and Comments?

1-888-880-6888

When Using This Product

do not get into eyes

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

Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Label

Section 50565-1 (50565-1)

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

Purpose

Skin Protectant

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredient

Zinc oxide 40%

Other Information
  • See box for more details
Inactive Ingredients

Sunflower oil, Castor Oil, Sunflower seed wax, polyhydroxystearic acid, shea butter, coconut oil, theobroma cacao seed butter, calophyllum seed oil, tocopherol, zea mays corn starch

Questions and Comments? (Questions and comments?)

1-888-880-6888

When Using This Product (When using this product)

do not get into eyes

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:19.285248 · Updated: 2026-03-14T23:00:42.428927