Label: PLACENTA EX EMULSION- dimethicone cream 

  • NDC Code(s): 51346-064-01
  • Packager: NATURE REPUBLIC CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 1.7%

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  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Glycerin, Cetyl Ethylhexanoate, Butylene Glycol, Mineral Oil, Niacinamide, Octyldodecyl Myristate, Polysorbate 60, Cetearyl Alcohol, Petrolatum, Pentylene Glycol, Glyceryl Stearate SE, Stearic Acid, Glycine Soja (Soybean)Phytoplacenta Extract, Macadamia Integrifolia Seed Oil, Sorbitan Sesquioleate, Beeswax, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Sorbitan Stearate, Phenoxyethanol, Fragrance (Parfum), Carbomer, Triethanolamine, Adenosine, Disodium EDTA, Alcohol, Gentiana Lutea Root Extract, Achillea Millefolium Extract, Artemisia Absinthium Extract, Arnica Montana Flower Extract, Potassium Sorbate, Citrus Aurantium Dulcis (Orange) Fruit Water, 1,2-Hexanediol, Hydrolyzed Collagen, Yellow 6

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  • PURPOSE

    Purpose: Brightening and wrinkle improvement.

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  • WARNINGS

    Cautions:
    For external use only.
    Avoid contact with eyes and mouth.
    Discontinue use if signs of irritation or rash appear.
    Keep out of reach of children.
    Replace the cap after use.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • INDICATIONS AND USAGE

    How to Use: After using our essence, apply an appropriate amount to the entire face.

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  • DOSAGE AND ADMINISTRATION

    How to Use: After using our essence, apply an appropriate amount to the entire face.

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  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    PLACENTA EX EMULSION 
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51346-064
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (Dimethicone) Dimethicone 2.38 g  in 140 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glycerin  
    Butylene Glycol  
    Mineral Oil  
    Niacinamide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51346-064-01 140 mL in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 10/01/2012
    Labeler - NATURE REPUBLIC CO., LTD. (631172020)
    Registrant - NATURE REPUBLIC CO., LTD. (631172020)
    Establishment
    Name Address ID/FEI Business Operations
    NATURE REPUBLIC CO., LTD. 631172020 manufacture(51346-064)
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