VITAMIN A AND D- lanolin, 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.

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Vitamin A and D Ointment

Active Ingredient

Lanolin 15.5%

Petrolatum 53.4%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash and helps seal out wetness

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

Directions

Change wet and soiled diapers promptly

Cleanse the diaper area and allow to dry

Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive ingredients

Cod liver oil (contains Vitamin A and D), fragrance, Mineral Oil, Microcrystalline Wax, Paraffin

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301

Product of PRC

www.trifecta-pharma.com

Warnings

For external use only

When using this product avoid contact with eyes

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

Questions call 1-888-296-9067

Packaging

vitamin_AD

VITAMIN A AND D 
lanolin, petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM53.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
COD LIVER OIL (UNII: BBL281NWFG)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-018-051 in 1 BOX01/05/2017
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-018-401 in 1 BOX12/19/2019
2113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/05/2017
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 5/2023
Document Id: fc498b3e-720f-a793-e053-6294a90a8498
Set id: 455a16fd-9ce5-6bef-e054-00144ff88e88
Version: 5
Effective Time: 20230522
 
Trifecta Pharmaceuticals USA LLC