ZINC OXIDE 20%- zinc oxide ointment

Zinc Oxide 20% by

Drug Labeling and Warnings

Zinc Oxide 20% by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Skin Protectant

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

Keep out of the reach of children

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

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.

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

Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Ste. 1500

Ft. Lauderdale, FL. 33301, USA.

Product of PRC

www.trifecta-pharma.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20% 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-021-54	1 in 1 JAR	07/01/2019
1		454 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2019

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)