VITAMIN A AND VITAMIN D ointment

Vitamin A and Vitamin D by

Drug Labeling and Warnings

Vitamin A and Vitamin D by is a Otc medication manufactured, distributed, or labeled by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

White Petrolatum (929.3 mg)

Purpose:

Emollient

INDICATIONS & USAGE

Uses:

• first aid in
• minor burns
• scalds
• sunburn
• windburn
• diaper rash
• chafing
• chapped skin
• nipple care
• abrasions
• cuts
• ulcers

WARNINGS

Warnings:

For external use only.

Ask doctor before use if you have severe or extensive burns.

When using this product the treatment of ulcers, severe cuts or wounds should be under the direction of a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

• cleanse affected area with mild soap and warm water
• dry thoroughly
• apply Vitamin A & Vitamin D ointment in a thin layer to the affected area directly to the skin or by spreading on sterile gauze or clean cloth
• bandage loosely

SPL UNCLASSIFIED SECTION

Other information:

• do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
• store at room temperature
• see crimp of tube for Lot Number and Exp. Date

Inactive Ingredients

fragrance, lanolin, paraffin, vitamin A (as palmitate), vitamin D

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

NDC: 0168-0035-01

Fougera®

Vitamin A & Vitamin D Ointment

(Emollient)

NET WT 56.70 g (2 Oz)

FOR EXTERNAL USE ONLY

DO NOT USE IN THE EYES

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

Fougera®

NDC: 0168-0035-01

Vitamin A & Vitamin D Ointment (Emollient)

To promote healing of minor skin irritaions

NET WT 2 Oz (56.70 g)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC: 0168-0035-45

Vitamin A & Vitamin D Ointment

(Emollient)

This product available in tubes at pharmacy

NET WT 5 g (approx. 5/32 Oz)

E. FOUGERA & CO.
A division of Fougera Pharamceuticals Inc., Melville, NY 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

NDC: 0168-0035-45

Fougera®

Vitamin A & Vitamin D
Ointment

(Emollient)

This product available in tubes at pharmacy

1 GROSS
5 g (approx. 5/32 Oz) FOILPACS®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC: 0168-0035-16

Vitamin A & Vitamin D
Ointment (Emollient)

NET WT 453.6 g (1 lb)

INGREDIENTS AND APPEARANCE

VITAMIN A AND VITAMIN D 
vitamin a and vitamin d ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	929.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
PARAFFIN (UNII: I9O0E3H2ZE)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
VITAMIN D (UNII: 9VU1KI44GP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0035-01	1 in 1 CARTON
1		56.70 g in 1 TUBE
2	NDC: 0168-0035-02	72 in 1 CARTON
2		56.70 g in 1 TUBE
3	NDC: 0168-0035-04	1 in 1 CARTON
3		113.4 g in 1 TUBE
4	NDC: 0168-0035-45	1 in 1 CARTON
4		5 g in 1 PACKET
5	NDC: 0168-0035-16	453.6 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/1981

Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)