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White Petrolatum by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Medically reviewed on August 30, 2017

Dosage form: ointment
Ingredients: PETROLATUM 1g in 1g
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
NDC Code: 0168-0053

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.

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

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®

WHITE PETROLATUM 
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0053
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:0168-0053-16453.6 g in 1 JAR
2NDC:0168-0053-211 TUBE in 1 CARTON
228.35 g in 1 TUBE
3NDC:0168-0053-31144 TUBE in 1 CARTON
328.35 g in 1 TUBE
4NDC:0168-0053-451 PACKET in 1 CARTON
45 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/1968
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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