WHITE PETROLATUM - petrolatum ointment 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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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Active Ingredient:

White Petrolatum USP 100%

Purpose:

Skin Protectant

Uses:

Warnings:

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions:

Other information:

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

L25316G

R12/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC 0168-0053-16

White Petrolatum USP

Skin Protectant

NET WT 453.6g (1 lb.)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL

WHITE PETROLATUM 
white petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0053
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 1 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0053-16 453.6 g in 1 JAR None
2 NDC:0168-0053-21 1 TUBE in 1 CARTON contains a TUBE
2 28.35 g in 1 TUBE This package is contained within the CARTON (0168-0053-21)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/01/1968

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

Revised: 07/2012 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.