PURE PETROLEUM ALOE WITH VITAMIN E OIL- white petroleum jelly

Pure Petroleum by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

White Petrolatum USP (99.9 %)

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

For the temporary protection of minor cuts, scrapes, burns and sunburn.

• Helps to temporarily protect chafed, chapped, cracked  or windburned skin and lips.

WARNINGS

Warnings

For External Use Only.

Do not use over deep or puncture wounds, infections or lacerations. Ask a doctor.

When using this product avoid contact with eyes.

Stop use and ask doctor if conditon worsens or does not improve within 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 product liberally, as often as necessary.

INACTIVE INGREDIENT

Inactive Ingredients

Aloe Vera Extract, Vitamin E and Fragrance

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Pure Petroleum Aloe with Vitamin E Oil Jelly

Net Wt. 4 oz. (113g)

INGREDIENTS AND APPEARANCE

PURE PETROLEUM   ALOE WITH VITAMIN E OIL
white petroleum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52920-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52920-127-35	100 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 52920-127-36	113 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 52920-127-37	170 g in 1 JAR; Type 0: Not a Combination Product
4	NDC: 52920-127-38	226 g in 1 JAR; Type 0: Not a Combination Product
5	NDC: 52920-127-39	283 g in 1 JAR; Type 0: Not a Combination Product
6	NDC: 52920-127-40	368 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/10/2015

Labeler - Singhfam Corporation (019499958)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52920-127)