PETROLEUM- white petroleum jelly

PETROLEUM by

Drug Labeling and Warnings

PETROLEUM by is a Otc medication manufactured, distributed, or labeled by Blue Cross Laboratories, Inc., 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 to soothe dry, chapped, cracked or irritated skin and lip due to cold and wind
• for the temporary protection of minor cuts, scrapes, burns and sunburn

WARNINGS

Warnings

For external use only

Avoid contact with eyes

Stop use and ask a doctor if condition worsens or does not improve after 7 days.

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• apply liberally, as often as necessary

INACTIVE INGREDIENT

Inactive ingredients

None

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

PETROLEUM JELLY
Skin Protectant
NET WT. 6 OZ (170 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PETROLEUM 
white petroleum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22431-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22431-705-01	113 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019
2	NDC: 22431-705-02	170 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019
3	NDC: 22431-705-03	226 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019
4	NDC: 22431-705-04	270 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019
5	NDC: 22431-705-05	368 g in 1 JAR; Type 0: Not a Combination Product	02/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/25/2019

Labeler - Blue Cross Laboratories, Inc. (008298879)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(22431-705)