WHITE PETROLATUM ointment

White Petrolatum by

Drug Labeling and Warnings

White Petrolatum 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 USP 100%

Purpose:

Skin Protectant

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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

SPL UNCLASSIFIED SECTION

Other information:

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

INACTIVE INGREDIENT

SPL UNCLASSIFIED SECTION

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

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 – CONTAINER

Fougera®

NDC: 0168-0053-21

White Petrolatum USP

Skin Protectant

NET WT 28.35g (1 Oz)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

Fougera®

NDC: 0168-0053-21

White
Petrolatum USP

Skin Protectant

Soothes minor skin irritations due to:
minor burns - scrapes - abrasions

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

Fougera®

NDC: 0168-0053-45

White Petrolatum USP

Skin Protectant

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

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

Fougera®

NDC: 0168-0053-45

White Petrolatum USP

Skin Protectant

This product is available as tubes at pharmacy.

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

INGREDIENTS AND APPEARANCE

WHITE PETROLATUM 
white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0168-0053
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0053-16	453.6 g in 1 JAR
2	NDC: 0168-0053-21	1 in 1 CARTON
2		28.35 g in 1 TUBE
3	NDC: 0168-0053-31	144 in 1 CARTON
3		28.35 g in 1 TUBE
4	NDC: 0168-0053-45	1 in 1 CARTON
4		5 g in 1 PACKET

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)