Zinc Oxide Ointment 20%

Zinc Oxide Ointment 20%
SPL v2
SPL
SPL Set ID 61f5aefe-9b43-a616-e053-2a91aa0acdbc
Route
TOPICAL
Published
Effective Date 2018-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.2 g)
Inactive Ingredients
Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-01-04
Description

Zinc Oxide 20%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 20%

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
Warnings

For External Use Only

  • 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.
Packaging

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.

Product of PRC

www.trifecta-pharma.com

Active Ingredient

Zinc Oxide 20%

Other Information
  • Store at controlled room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredients

Mineral Oil, Petrolatum

Keep Out of the Reach of Children

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

Structured Label Content

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
  • 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.
Packaging

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.

Product of PRC

www.trifecta-pharma.com

Active Ingredient

Zinc Oxide 20%

Other Information
  • Store at controlled room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredients

Mineral Oil, Petrolatum

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

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:29.924853 · Updated: 2026-03-14T22:55:00.598631