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

Purpose

Skin Protectant

Description

Zinc Oxide 20%


Medication Information

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.
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

Mineral Oil, Petrolatum

Description

Zinc Oxide 20%

Packaging

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%

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
  • 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.
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

Mineral Oil, Petrolatum

Packaging

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%

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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