RxNorm Names

Not yet provided

PETROLEUM (white petrolatum) jelly
[Demoulas Supermarkets, Inc]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a3400c92-d37d-4f80-87b2-2a8e1a4468e4

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredients

Active Ingredients

White Petrolatum USP (100%)

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash
protects chafed skin due to diaper rash
helps seal out wetness

Warnings

For external use only

Do not use on

deep or puncture wounds
animal bites
serious burns

When using this product

do not get into eyes

Stop use and ask a doctor

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

change wet and soilded diapers promptly
cleanse the diaper area, and allow to dry
apply product liberally as often as necessary, with each diaper change, and expecially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive ingredient

Inactive ingredient fragrance

Disclaimer

This product is not manufactured or distributed by Unilever, distributer of Vaseline Baby

Adverse reaction

Distributed By

Demoulas Supermarkets, Inc

875 East Street

Tweksbury, MA 01876

Principal Display

MORE FOR YOUR DOLLAR

Compare to Vaseline Baby

MARKET BASKET

BABY

petroleum

jelly

Skin

Protectant

NET WT 13 oz (368 g)

image description

PETROLEUM
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53942-519
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (PETROLATUM)	PETROLATUM	1000 mg in 100 g

Packaging
#	Item Code	Package Description
1	NDC:53942-519-27	368 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2010

Labeler - Demoulas Supermarkets, Inc (007869647)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(53942-519)

Revised: 11/2012

Document Id: 5613f28b-d7fd-401a-b221-bef80ba31cfc

Set id: a3400c92-d37d-4f80-87b2-2a8e1a4468e4

Version: 1

Effective Time: 20121106