zinc oxide ointment 20%

SPL v2

SPL

SPL Set ID fcef17f1-84e7-a288-e053-6294a90a064b

Route

topical

Published

Effective Date 2023-05-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

zinc oxide (0.2 g)

Inactive Ingredients

white petrolatum ceteth-20 light mineral oil cetostearyl alcohol

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-05-30

Purpose

Skin Protectant

Description

Zinc Oxide 20%

Medication Information

Warnings

For External Use Only

When using this product avoid contact with eyes

Uses

Protects skin
Protects and releives chafed skin due to diaper rash - helps seal out wetness
Dries the oozing and weeping of poison ivy, oak and sumac

Purpose

Skin Protectant

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

Other Information

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

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Light Mineral Oil, White Petrolatum

Description

Zinc Oxide 20%

Section 51945-4

Questions

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA, LLC.®

101 NE Third Avenue, Ste. 1500

Ft. Lauderdale, FL. 33301, USA.

www.trifecta-pharma.com

Active Ingredient

Zinc Oxide 20%

Stop Use and Ask Doctor If

Stop use and ask doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

Keep Out of the Reach of Children

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

Structured Label Content

Warnings

For External Use Only

When using this product avoid contact with eyes

Uses

Protects skin
Protects and releives chafed skin due to diaper rash - helps seal out wetness
Dries the oozing and weeping of poison ivy, oak and sumac

Purpose

Skin Protectant

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

Other Information

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

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Light Mineral Oil, White Petrolatum

Section 51945-4 (51945-4)

Questions

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA, LLC.®

101 NE Third Avenue, Ste. 1500

Ft. Lauderdale, FL. 33301, USA.

www.trifecta-pharma.com

Active Ingredient

Zinc Oxide 20%

Stop Use and Ask Doctor If (Stop Use and ask Doctor if)

Stop use and ask doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

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

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

Advanced Ingredient Data

[{"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETETH-20", "unii": "I835H2IHHX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Protects skin Protects and releives chafed skin due to diaper rash - helps seal out wetness Dries the oozing and weeping of poison ivy, oak and sumac", "Purpose": "Skin Protectant", "Warnings": "For External Use Only When using this product avoid contact with eyes", "Questions": "Call 1-888-296-9067", "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", "Distributed By:": "Trifecta Pharmaceuticals USA, LLC.® 101 NE Third Avenue, Ste. 1500 Ft. Lauderdale, FL. 33301, USA. www.trifecta-pharma.com", "Active Ingredient": "Zinc Oxide 20%", "Other Information": "Store at controlled room temperature 15° - 30°C (59° - 86°F)", "Inactive Ingredients": "Cetomacrogol 1000, Cetostearyl alcohol, Light Mineral Oil, White Petrolatum", "Stop Use and ask Doctor if": "Stop use and ask doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.", "Keep out of the reach of children": "If swallowed, get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.493261 · Updated: 2026-03-14T23:02:25.522673