WHITE PETROLATUM

Main information

  • Trade name:
  • WHITE PETROLATUM- white petrolatum ointment
  • Composition:
  • PETROLATUM 1 g in 1 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • WHITE PETROLATUM- white petrolatum ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • 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

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 0168-0053-16, 0168-0053-21, 0168-0053-31, 0168-0053-45
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

WHITE PETROLATUM- white 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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White Petrolatum USP

Active Ingredient:

White Petrolatum USP 100%

Purpos e:

Skin Protectant

Us es :

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 16 8 -0 0 53

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)

PETROLATUM

1 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 16 8 -0 0 53-16

453.6 g in 1 JAR

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

2

NDC:0 16 8 -0 0 53-21

1 in 1 CARTON

2

28 .35 g in 1 TUBE

3

NDC:0 16 8 -0 0 53-31

144 in 1 CARTON

3

28 .35 g in 1 TUBE

4

NDC:0 16 8 -0 0 53-45

1 in 1 CARTON

4

5 g in 1 PACKET

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 1/0 1/19 6 8

Labeler -

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

Revised: 8/2012