BABY PETROLEUM JELLY- white petrolatum cream

Baby Petroleum Jelly by

Drug Labeling and Warnings

Baby Petroleum Jelly by is a Otc medication manufactured, distributed, or labeled by Rejoice International Inc., Jell Pharmaceuticals Pvt Ltd., Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                      Purpose

White Petroleum 99.9% ...... skin protectant

PURPOSE

Uses

temporarily protects and helps relieve chapped or cracked skin and lips

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.

INDICATIONS & USAGE

XtraCare

100% Pure Petroleum Jelly

Baby Fresh Scent

DOSAGE & ADMINISTRATION

Directions

• change and cleanse diaper area, and allow to dry
• apply product as needed, with each diaper change, especially at bedtime and when exposure to wet diapers may be prolonged

WARNINGS

Warnings

For external use only

When using this product do not get into eyes

See a doctor if condition lasts more than 7 days

Do not use on

• deep puncture wounds
• animal bites
• serious burns

INACTIVE INGREDIENT

Inactive ingredients fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY PETROLEUM JELLY 
white petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-076-01	113 g in 1 PACKAGE; Type 0: Not a Combination Product	06/15/2015
2	NDC: 57337-076-02	170 g in 1 PACKAGE; Type 0: Not a Combination Product	06/15/2015
3	NDC: 57337-076-03	227 g in 1 PACKAGE; Type 0: Not a Combination Product	06/15/2015
4	NDC: 57337-076-04	368 g in 1 PACKAGE; Type 0: Not a Combination Product	06/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/15/2015

Labeler - Rejoice International Inc. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(57337-076)