Zinc Oxide Ointment

Zinc Oxide Ointment
SPL v3
SPL
SPL Set ID 2cb7f314-beb4-e57f-e063-6394a90ad3ef
Route
TOPICAL
Published
Effective Date 2025-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Ceteth-20 Light Mineral Oil Cetostearyl Alcohol White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Zinc Oxide 20%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 20%

Use

Helps treat chafed skin associated with diaper rash

Dries the oozing and weeping of poison: • ivy • oak •sumac

Warnings

For External Use Only.

Directions

• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area,

and allow to dry.

• Apply ointment liberally as often as necessary with each diaper

change, especially at bedtime or anytime when exposure to wet diapers may be

prolonged.

• For poison ivy, oak, and sumac: Apply as needed.

Active Ingredient

Zinc Oxide 20%

Other Information
  • Store at room temperature between 15º - 30ºC (59º - 86ºF)
  • Avoid excessive heat
  • Tamper evident. Do not use if seal is damaged.
Inactive Ingredients

CETETH-20, CETOSTEARYL ALCOHOL, LIGHT MINERAL OIL, WHITE PETROLATUM

Questions Or Comments?

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product
  • Avoid contact with 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
Keep Out of Reach of Children

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

Package/label Principal Display Panel

NDC: 84289-119-20

ZINC OXIDE OINTMENT

Skin Protectant

Net Wt 1 oz. (28.4 g)

GOA/DRUGS/571


Structured Label Content

Use (USE)

Helps treat chafed skin associated with diaper rash

Dries the oozing and weeping of poison: • ivy • oak •sumac

Purpose (PURPOSE)

Skin Protectant

Warnings (WARNINGS)

For External Use Only.

Directions (DIRECTIONS)

• For diaper rash: Change wet and soiled diapers promptly, cleanse the diaper area,

and allow to dry.

• Apply ointment liberally as often as necessary with each diaper

change, especially at bedtime or anytime when exposure to wet diapers may be

prolonged.

• For poison ivy, oak, and sumac: Apply as needed.

Active Ingredient (ACTIVE INGREDIENT)

Zinc Oxide 20%

Other Information (OTHER INFORMATION)
  • Store at room temperature between 15º - 30ºC (59º - 86ºF)
  • Avoid excessive heat
  • Tamper evident. Do not use if seal is damaged.
Inactive Ingredients (INACTIVE INGREDIENTS)

CETETH-20, CETOSTEARYL ALCOHOL, LIGHT MINERAL OIL, WHITE PETROLATUM

Questions Or Comments? (QUESTIONS OR COMMENTS?)

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product (When using this product)
  • Avoid contact with 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 (1-800-222-1222) right away

Package/label Principal Display Panel (PACKAGE/LABEL PRINCIPAL DISPLAY PANEL)

NDC: 84289-119-20

ZINC OXIDE OINTMENT

Skin Protectant

Net Wt 1 oz. (28.4 g)

GOA/DRUGS/571


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)