SPL v1
SPL
SPL Set ID 37a30ee5-fd33-b410-e063-6294a90aef72
Route
TOPICAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Light Mineral Oil White Petrolatum Cetostearyl Alcohol Ceteareth-20

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16
Description

Zinc Oxide

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
  • dries the ozzing and weeping of poison ivy, poison oak and posion sumac
Section 51945-4

Warnings

Warnings

For external use only.

Directions

Directions:

For Diaper Rash:

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

For poison ivy, oak and suman: apply as needed

Active Ingredient

Zinc Oxide

Inactive Ingredients

Inactive ingredients: Ceteareth 20, Cetostearyl Alcohol, Light Mineral Oil, Petrolatum

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
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

Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
  • dries the ozzing and weeping of poison ivy, poison oak and posion sumac
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

Warnings

For external use only.

Directions

Directions:

For Diaper Rash:

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

For poison ivy, oak and suman: apply as needed

Active Ingredient

Zinc Oxide

Inactive Ingredients (Inactive ingredients)

Inactive ingredients: Ceteareth 20, Cetostearyl Alcohol, Light Mineral Oil, Petrolatum

When Using This Product (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)

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)

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: 2026-02-15T12:06:19.621541 · Updated: 2026-03-14T23:09:01.566522