Label: ROYAL CREAMY PETROLEUM COCOA SCENT- petrolatum jelly

  • NDC Code(s): 76176-352-01
  • Packager: NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 1, 2020

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  • DESCRIPTION

    Creamy Petroleum Jelly is specially formulated to moisture, 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:

    Petrolatum 30%

  • Purpose

    Skin Protectant

  • Uses:

    • Temporarily protects minor cuts, scrapes, and 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.

    When using this product do not get into eyes.

    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use on deep puncture wounds.

  • 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), Mineral Oil, Cetearyl Alcohol, Glyceryl Stearate, Glycerin, Ceteareth-20, Propylene Glycol, Carbomer, Dimethicone, Triethanolamine, Fragrance, Tocopheryl Acetate, Theobroma Cacao (Cocoa) Seed Butter (Cocoa Butter), Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Yellow No. 5, FD&C Red No. 40.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ROYAL CREAMY PETROLEUM COCOA SCENT 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-352
    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
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETEARETH-22 (UNII: 28VZG1E234)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-352-01198 g in 1 TUBE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2020
    Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
    Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.530766098manufacture(76176-352)
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