ROYAL PETROLEUM (VITAMIN E ENRICHED)- petrolatum jelly

Royal Petroleum (Vitamin E Enriched) by

Drug Labeling and Warnings

Royal Petroleum (Vitamin E Enriched) by is a Otc medication manufactured, distributed, or labeled by Filo America, NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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. Great for moisturizing face and neck.

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.

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.

SPL UNCLASSIFIED SECTION

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

MADE IN CHINA

DISTRIBUTED BY:
Filo America

P.O. Box 23592

Los Angeles, CA 90023

Questions or Concerns?

1.866.460.0322

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYAL PETROLEUM (VITAMIN E ENRICHED) 
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50438-401
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)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50438-401-01	198 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/19/2014

Labeler - Filo America (943873703)

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(50438-401)