UNIVERSAL COCOA BUTTER SCENT PETROLEUM- white petroleum jelly

UNIVERSAL COCOA BUTTER SCENT PETROLEUM by

Drug Labeling and Warnings

UNIVERSAL COCOA BUTTER SCENT PETROLEUM by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Orchid Lifesciences. 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 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

Fragrance

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Universal Cocoa Butter Scent Petroleum
Jelly
Net Wt. 8 OZ (226 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNIVERSAL COCOA BUTTER SCENT PETROLEUM 
white petroleum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-102
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
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-102-01	170 g in 1 JAR; Type 0: Not a Combination Product	11/01/2019
2	NDC: 52000-102-02	226 g in 1 JAR; Type 0: Not a Combination Product	11/01/2019
3	NDC: 52000-102-03	368 g in 1 JAR; Type 0: Not a Combination Product	11/01/2019
4	NDC: 52000-102-04	510 g in 1 JAR; Type 0: Not a Combination Product	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	11/01/2019

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Orchid Lifesciences (675474890)

Establishment
Name	Address	ID/FEI	Business Operations
Orchid Lifesciences		675474890	manufacture(52000-102)