ASSURED CREAMY COCOA BUTTER PETROLEUM VITAMIN E ENRICHED- petrolatum jelly

Assured Creamy Cocoa Butter Petroleum Vitamin E Enriched by

Drug Labeling and Warnings

Assured Creamy Cocoa Butter Petroleum Vitamin E Enriched by is a Otc medication manufactured, distributed, or labeled by GREENBRIER INTERNATIONAL, NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PETROLEUM JELLY

Creamy petroleum Jelly is specially formulated to moisturize, soften and soothe dry skin. Blended with Vitamin E to produce a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness.

ACTIVE INGREDIENT

DRUG FACTS  

Active Ingredient                                 Purpose

Petrolatum 30%                                      Skin Protectant

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

temporarily protects minor:

cuts  scrapes  burns

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

WARNINGS

Warnings

For external use only. Do not use on deep puncture wounds, animal bites and serious burns.

WHEN USING

When using this product, do not get into eyes

STOP USE

Stop use and ask doctor if

condition worsens

Symptoms last more than 7 days

clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions: apply as needed

INACTIVE INGREDIENT

Inactive ingredients:

water (Aqua),  Carbopol 940, Stearic Acid, Glyceryl Monostearate, Mineral Oil, Cetearyl Alcohol, GE125 Emulsifying Agent, Methylparaben, Propyparaben, Triethanolamine, Tocopheryl Acetate, Cocoa Butter, Fragrance,Yellow 5, Yellow 6, Red 33, Blue 1.

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Unilever, distributor of the registered trademark Vaseline (r)

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC

CHESAPEAKE VA 23320

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED CREAMY COCOA BUTTER PETROLEUM VITAMIN E ENRICHED 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-1310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
COCOA BUTTER (UNII: 512OYT1CRR)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-1310-1	127 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/25/2013

Labeler - GREENBRIER INTERNATIONAL (610322518)

Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.		529047265	manufacture(33992-1310)