ZINC OXIDE 20%- zinc oxide ointment 
Trifecta Pharmaceuticals USA

----------

Zinc Oxide Ointment 20%

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

Keep out of the reach of children

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

Warnings

For External Use Only

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

Other Information

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

Globe Zinc Oxide Ointment 2oz India Rev09 042323 CDER

ZINC OXIDE 20% 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-086
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
CETETH-20 (UNII: I835H2IHHX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-086-021 in 1 BOX05/30/2023
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01605/30/2023
Labeler - Trifecta Pharmaceuticals USA (079424163)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 1/2024
Document Id: 0f4e022b-3f1e-96dc-e063-6294a90ad3b7
Set id: fcef17f1-84e7-a288-e053-6294a90a064b
Version: 2
Effective Time: 20240119
 
Trifecta Pharmaceuticals USA