UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED- white petroleum jelly

UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED by

Drug Labeling and Warnings

UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

White Petrolatum USP (100 %)

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 condition 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 as liberally, as often as necessary.

INACTIVE INGREDIENT

Inactive ingredients

None

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED JELLY
SKIN PROTECTANT
NET WT. 13 OZ (368 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED 
white petroleum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-007
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

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.0001 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-007-19	226 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020
2	NDC: 52000-007-20	45 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020
3	NDC: 52000-007-21	100 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020
4	NDC: 52000-007-22	113 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020
5	NDC: 52000-007-23	170 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020
6	NDC: 52000-007-24	198 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020
7	NDC: 52000-007-25	283 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020
8	NDC: 52000-007-26	368 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020
9	NDC: 52000-007-27	450 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020
10	NDC: 52000-007-28	500 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/06/2013

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52000-007)