Zinc Oxide Ointment Usp

Zinc Oxide Ointment Usp
SPL v6
SPL
SPL Set ID 7b42655b-2163-4637-9f5d-1d2efa1bdf1d
Route
TOPICAL
Published
Effective Date 2025-02-03
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-10

Description

Zinc Oxide 20% w/w

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 20% w/w

Uses

• Protects skin

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

• Protects and relieves chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

Directions

• Apply ointment liberally as often as necessary

• For the treatment of diaper rash, change wet and soiled diapers promptly

• Cleanse the diaper area and allow to dry

• Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Active Ingredient

Zinc Oxide 20% w/w

Other Information

• Store at controlled room temperature 15°- 30°C (59°- 86°F).

• Avoid excessive heat.

Inactive Ingredients

Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin.

Principal Display Panel

NDC 75834-170-01

Zinc Oxide Ointment USP

Zinc Oxide 20%



Skin Protectant

Net Wt. 1 oz. (28.4 g)



Nivagen Pharmaceuticals



















NDC 75834-170-02

Zinc Oxide Ointment USP

Zinc Oxide 20%



Skin Protectant

Net Wt. 2 oz. (56.7 g)



Nivagen















NDC 75834-170-15

Zinc Oxide Ointment USP

Zinc Oxide 20%



Skin Protectant

Net Wt. 15 oz. (425 g)



Nivagen







When Using This Product

• avoid contact with eyes

• Stop use and ask a doctor if condition worsens or does not improve within 7 days.

This may be a sign of a serious condition.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

• Protects skin

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

• Protects and relieves chafed skin due to diaper rash and helps seal out wetness

Purpose

Skin Protectant

Warnings

For external use only

Directions

• Apply ointment liberally as often as necessary

• For the treatment of diaper rash, change wet and soiled diapers promptly

• Cleanse the diaper area and allow to dry

• Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

Active Ingredient

Zinc Oxide 20% w/w

Other Information

• Store at controlled room temperature 15°- 30°C (59°- 86°F).

• Avoid excessive heat.

Inactive Ingredients

Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 75834-170-01

Zinc Oxide Ointment USP

Zinc Oxide 20%



Skin Protectant

Net Wt. 1 oz. (28.4 g)



Nivagen Pharmaceuticals



















NDC 75834-170-02

Zinc Oxide Ointment USP

Zinc Oxide 20%



Skin Protectant

Net Wt. 2 oz. (56.7 g)



Nivagen















NDC 75834-170-15

Zinc Oxide Ointment USP

Zinc Oxide 20%



Skin Protectant

Net Wt. 15 oz. (425 g)



Nivagen







When Using This Product (When using this product)

• avoid contact with eyes

• Stop use and ask a doctor if condition worsens or does not improve within 7 days.

This may be a sign of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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