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 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.

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

Distributed By:

Trifecta Pharmaceuticals USA, LLC.®

101 NE Third Avenue, Ste. 1500

Ft. Lauderdale, FL. 33301, USA.

www.trifecta-pharma.com

Questions

Call 1-888-296-9067

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20% 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-086
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
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
CETETH-20 (UNII: I835H2IHHX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-086-02	1 in 1 BOX	05/30/2023
1		60 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 Drug	M016	05/30/2023

Labeler - Trifecta Pharmaceuticals USA (079424163)

Registrant - Trifecta Pharmaceuticals USA (079424163)