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

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White Petrolatum USP

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

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

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 – CONTAINER

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 – CARTON

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 – CONTAINER

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®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
WHITE PETROLATUM 
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0168-0053-16453.6 g in 1 JAR; Type 0: Not a Combination Product01/01/196806/30/2021
2NDC:0168-0053-211 in 1 CARTON01/01/196805/31/2021
228.35 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0168-0053-31144 in 1 CARTON01/01/196810/31/2014
328.35 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:0168-0053-451 in 1 CARTON01/01/196807/31/2017
45 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01601/01/196806/30/2021
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
Establishment
NameAddressID/FEIBusiness Operations
Fougera Pharmaceuticals Inc.043838424ANALYSIS(0168-0053)

Revised: 1/2022
 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.