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

  • 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

Globe Zinc Oxide Ointment

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:69396-021-021 in 1 BOX01/26/2018
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 finalpart34701/26/2018
Labeler - Trifecta Pharmaceuticals USA (079424163)

Revised: 8/2021
Document Id: c94b053a-5a93-4fb4-e053-2a95a90a2c61
Set id: 63b551fc-7d16-c099-e053-2a91aa0a5f2c
Version: 2
Effective Time: 20210811
 
Trifecta Pharmaceuticals USA