ZINC OXIDE 20%- zinc oxide ointment 
Trifecta Pharmaceuticals USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Directions

Other Information

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

Globe ZInc Oxide 16oz. Jar

ZINC OXIDE 20% 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-021
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
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-021-541 in 1 JAR07/01/2019
1454 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/2019
Labeler - Trifecta Pharmaceuticals USA (079424163)

Revised: 4/2023
Document Id: fa15ac73-f4f5-7a6b-e053-6294a90a4f4e
Set id: 8cbe9b1f-fec0-9579-e053-2995a90ac461
Version: 7
Effective Time: 20230424
 
Trifecta Pharmaceuticals USA