VITAMIN A AND D- petrolatum ointment 
Trifecta Pharmaceuticals USA LLC

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.

----------

Globe Vitamin A & D Ointment

Active Ingredient

Petrolatum 76%

Purpose

Skin Protectant

Uses

Temporarily protects and relieves

Stop use and ask a doctor

Condition worsens

Symptoms last more than 7 days or clear up and occur again with a few days

Keep out of reach of children

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

When using this product

Avoid contact with eyes

Do Not Use

Directions

Apply as needed

Inactive ingredients

mineral oil, vitamin A Palmitate, vitamin D3, Microcrystalline Wax, Paraffin

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

www.trifecta-pharma.com

1-888-296-9067

Warnings

For external use only

Questions

Call: 1-888-296-9067

Store at room temperature 20º-25ºC (68º-77ºF)

Tamper evident, do not use if packet is torn, cut or opened

Avoid excessive heat and humidity

Globe A and D Ointment 5g CDER

VITAMIN A AND D 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-121-05144 in 1 CARTON10/14/2022
15 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/14/2022
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 3/2023
Document Id: f71f002e-9e8e-2b26-e053-6294a90ac27b
Set id: f1ea9640-4a6d-1c76-e053-2a95a90ad3b1
Version: 3
Effective Time: 20230317
 
Trifecta Pharmaceuticals USA LLC