1190, 1191, 1192 Zinc Oxide Ointment 20%

1190, 1191, 1192 Zinc Oxide Ointment 20%
SPL v1
SPL
SPL Set ID 11d79dd6-35f7-4399-e063-6294a90ac7dd
Route
TOPICAL
Published
Effective Date 2024-02-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-29

Description

Zinc Oxide 20%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 20%

Label

Label 1192

Use(s)

• Helps treat chafed skin associated with diaper rash

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

Questions?

1-888-Dynarex Monday - Friday, 9AM - 5PM EST.

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

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

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.


Structured Label Content

Label

Label 1192

Use(s)

• Helps treat chafed skin associated with diaper rash

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

Purpose

Skin Protectant

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.

Questions?

1-888-Dynarex Monday - Friday, 9AM - 5PM EST.

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

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

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.


Advanced Ingredient Data


Raw Label Data

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