Label: 3CE WHITE MILK CREA M- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL

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 October 14, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 1.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Propanediol, Glycerin, Butylene Glycol, Niacinamide, Titanium Dioxide (CI 77891), Cyclopentasiloxane, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Isohexadecane, Polysorbate 80, Dimethiconol, Sodium PolyacryloyldimethylTaurate, Phenoxyethanol, Hydrogenated Polydecene, Chlorphenesin, Ethylhexylglycerin, Caprylyl Glycol, Betaine, Alcohol, Milk Protein Extract, Trideceth-10, Triethoxycaprylylsilane, Adenosine, Disodium EDTA, Fragrance, Sodium Hyaluronate, Tocopheryl Acetate, Theobroma cacao (Cocoa) seed Butter

  • PURPOSE

    Purpose: Skin Protectant

  • CAUTION

    CAUTION: 1. If following problems occur upon using the product, stop use immediately, further use may worsen the symptoms. Consult with a dermatologist if necessary. 1) Red spots, swelling, itchiness, irritation, or any other irregularities. 2) If applied area show above symptoms when exposed to direct sunlight. 2. Do not use on areas shows above symptoms when exposed to direct sunlight. 3. Notes on storage and handling 1) Always put the lid back on after use 2) Keep away from reach of children 3) Keep away from high/ low temperature or direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from reach of children

  • INSTRUCTIONS

    INSTRUCTIONS: Anti-wrinkle & brighten cream that daily apply on any parts(face and body) you wish to be brightened up.

  • Directions

    Directions: At the last step of your skin care routine, apply a small amount on neck, arms, legs and any other areas of your body that you wish to brighten your skin tone. Make sure to close the lid after use.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE WHITE MILK CREA M 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.75 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propanediol (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-125-021 in 1 CARTON08/20/2016
    1NDC:60764-125-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/20/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-125)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co., Ltd.688830827manufacture(60764-125)
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