BABY PETROLEUM- petrolatum jelly

Baby Petroleum by

Drug Labeling and Warnings

Baby Petroleum by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

White Petrolatum USP (100%)

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

Uses

• helps treat and prevent diaper rash

• protects chafed skin due to diaper rash

• helps seal out wetness

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

WHEN USING

When using this product do not get into eyes.

STOP USE

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.

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

Inactive ingredient

Fragrance

QUESTIONS

Questions or comments?

1-800-925-4733

SPL UNCLASSIFIED SECTION

Package/Label Principal Display Panel

Baby Petroleum Jelly

Skin Protectant

Fresh Scent

Compare to Vaseline® Baby Petroleum Jelly

NET WT 13 OZ (368 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY PETROLEUM 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0731
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	100 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0731-13	368 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/17/2014

Labeler - Walgreen Company (008965063)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(0363-0731)