SHEA BUTTER PETROLEUM JELLY- petrolatum jelly jelly

Shea Butter Petroleum Jelly by

Drug Labeling and Warnings

Shea Butter Petroleum Jelly by is a Otc medication manufactured, distributed, or labeled by Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SHEA BUTTER PETROLEUM JELLY 
petrolatum jelly jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30400-501
Route of Administration	TOPICAL

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

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30400-501-01	368 g in 1 JAR; Type 0: Not a Combination Product	10/11/2021
2	NDC: 30400-501-02	49 g in 1 JAR; Type 0: Not a Combination Product	10/11/2021
3	NDC: 30400-501-03	100 g in 1 JAR; Type 0: Not a Combination Product	10/11/2021
4	NDC: 30400-501-04	113 g in 1 JAR; Type 0: Not a Combination Product	10/11/2021
5	NDC: 30400-501-05	170 g in 1 JAR; Type 0: Not a Combination Product	10/11/2021
6	NDC: 30400-501-06	425 g in 1 JAR; Type 0: Not a Combination Product	10/11/2021
7	NDC: 30400-501-07	226 g in 1 JAR; Type 0: Not a Combination Product	10/11/2021
8	NDC: 30400-501-08	283 g in 1 JAR; Type 0: Not a Combination Product	10/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/10/2021

Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(30400-501)