SHEA BUTTER PETROLEUM JELLY- petrolatum jelly jelly
Walgreens

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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Active Ingredient

White Petrolatum USP (99.6%)

Purpose

Skin Protectant

Uses

temporarily protects minor: cuts, scrapes, burns; temporarily protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

condition worsens, symptoms last longer than 7 days or clear up and occur again within a few days

Do not use on

deep or puncture wounds, animal bites, serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply as needed

Inactive ingredients

butyrospermum parkii (shea butter), fragrance

Questions or comments?

1-800-925-4733

Label

SHEA BUTTER PETROLEUM JELLY
petrolatum jelly jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0740
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.6 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SHEA BUTTER (UNII: K49155WL9Y)	0.1 g in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0740-13	368 g in 1 JAR; Type 0: Not a Combination Product	06/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/14/2016

Labeler - Walgreens (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
Unipack, Inc.		009248480	manufacture(0363-0740)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(0363-0740)