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 Pharmacy Value Alliance, LLC, Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Protects chafed skin due to diaper rash - helps protect skin from wetness
• Protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac
• Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips

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

• 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 betime or anytime when exposure to wet diapers may be prolonged

Other Information

• Store at controlled room temperature 20° - 25°C (68° - 77°F)

Inactive Ingredients

Mineral Oil, Petrolatum

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Packaging

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20% 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-159
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: 68016-159-02	1 in 1 BOX	07/19/2016
1		57 g in 1 TUBE; 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	07/19/2016

Labeler - Pharmacy Value Alliance, LLC (101668460)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)