PURE PETROLATUM JELLY- petrolatum jelly

Pure Petrolatum Jelly by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

White Petrolatum (100% w/w)

Purpose

Skin protectant

Uses

• temporarily protects minor cuts, scrapes, burns and sunburn
• temporarily protects and helps relieve chapped or cracked skin
• helps protect from the drying effects of wind and cold weather
• helps treat and prevent diaper rash
• helps seal out wetness

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 for more than 7 days or clean up and occur again in 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 Ingredient

none

Package Label

INGREDIENTS AND APPEARANCE

PURE PETROLATUM JELLY 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30400-509
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30400-509-01	368 g in 1 JAR; Type 0: Not a Combination Product	10/15/2016
2	NDC: 30400-509-02	226 g in 1 JAR; Type 0: Not a Combination Product	10/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/15/2016

Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt Ltd.		726025211	manufacture(30400-509)