Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 99d4b52c-b63b-4901-bfea-d529a1d8cd24
Route
TOPICAL
Published
Effective Date 2013-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Cod Liver Oil Lanolin Methylparaben Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-09-01
Description

Zinc Oxide 20%

Purpose

Skin Protectant

Medication Information

Warnings and Precautions

For external use only.

Purpose

Skin Protectant

Description

Zinc Oxide 20%

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

Directions
  • change wet or soiled diapers promptly
  • clean the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.
Active Ingredient

Zinc Oxide 20%

Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients

bees wax, BHT, cod liver oil, fragrance, lanolin, methylparaben, petrolatum, purified water

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 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
  • helps seal out wetness
Warnings and Precautions (34071-1)

For external use only.

Section 51945-4 (51945-4)

Purpose

Skin Protectant

Directions
  • change wet or soiled diapers promptly
  • clean the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.
Active Ingredient

Zinc Oxide 20%

Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients

bees wax, BHT, cod liver oil, fragrance, lanolin, methylparaben, petrolatum, purified water

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 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:41.564477 · Updated: 2026-03-14T22:53:35.209708