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Vitamin A and D by Trifecta Pharmaceuticals USA LLC

Dosage form: ointment
Ingredients: PETROLATUM 53.4g in 100g, LANOLIN 15.5g in 100g
Labeler: Trifecta Pharmaceuticals USA LLC
NDC Code: 69396-018

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.

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 A AND D 
lanolin, petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-018
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM53.4 g  in 100 g
LANOLIN (LANOLIN) LANOLIN15.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
COD LIVER OIL 
MICROCRYSTALLINE WAX 
PARAFFIN 
Packaging
#Item CodePackage Description
1NDC:69396-018-051 TUBE in 1 BOX
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/05/2017
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 11/2017
 
Trifecta Pharmaceuticals USA LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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