ROYAL PETROLEUM (VITAMIN E ENRICHED)- petrolatum jelly 
Filo America

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Fact

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.

DRUG FACTS  

Active Ingredient                                     Purpose

Petrolatum 30%                                      Skin Protectant

Purpose

Skin Protectant

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

For external use only. Do not use on deep puncture wounds.

When using this product, do not get into eyes

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions: apply as needed

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.

*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

vitamin e enriched

ROYAL PETROLEUM (VITAMIN E ENRICHED) 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50438-401-01198 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/19/2014
Labeler - Filo America (943873703)
Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.529047265manufacture(50438-401)

Revised: 2/2014
Document Id: bee0a22f-1615-45d0-bbf5-f30c48b0fe62
Set id: a32070de-5501-46dc-a4d8-61f45d377e78
Version: 1
Effective Time: 20140219
 
Filo America