ROYAL PETROLEUM (COCOA SCENT) (PETROLATUM) JELLY [FILO AMERICA]

ROYAL PETROLEUM (COCOA SCENT) (PETROLATUM) JELLY [FILO AMERICA]
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NDC 50438-400-01
Set ID 155b0ce0-b930-4b8a-8c77-697677904b90
Category HUMAN OTC DRUG LABEL
Packager Filo America
Generic Name
Product Class
Product Number
Application Number PART347
  • 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

    cocoa scent

  • INGREDIENTS AND APPEARANCE
    ROYAL PETROLEUM (COCOA SCENT) 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-400
    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:50438-400-01198 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(50438-400)

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