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:

temporary protection of minor
cuts
scrapes
burns
sunburn
chafed or chapped skin
helps treat and prevent diaper rash
protects chafed skin due to diaper rash and helps protect from wetness

Warnings:

For external use only

When using this product

avoid contact with eyes
not to be applied over deep or puncture wounds, infections or lacerations

Stop use and ask a doctor if

the condition persists or gets worse
if a rash or other allergic reaction develops

Keep out of reach of children.

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

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

Other information:

store at room temperature 15°-30°C (59°-86°F)
do not sure if seal is broken or missing

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.