Label: 3CE FIXER AND MASCARA BLACK- allantoin liquid

  • NDC Code(s): 60764-133-01, 60764-133-02
  • Packager: Nanda Co., Ltd
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 17, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.1%

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  • INACTIVE INGREDIENT

    Mascara Inactive Ingredients: Water, Acrylates Copolymer, Iron Oxides (CI 77499), Beeswax, Stearic Acid, Butylene Glycol, Acetylated Sucrose Distearate, CoperniciaCerifera (Carnauba) Wax, Alcohol Denat., Triethanolamine, Octylacrylamide/Acrylates/Butylaminoethyl Methacrylate Copolymer, Polysorbate 20, Behenyl Alcohol, Cellulose, Tromethamine, Montmorillonite, Nylon-66, Polyvinyl Alcohol, SorbitanSesquioleate, Phenoxyethanol, Methylparaben, Dimethicone, Propylparaben, Silica, Disodium EDTA, Titanium Dioxide (CI 77891), Potassium Hydroxide, Diamond powder, Polymethylsilsesquioxane, Amethyst Powder, Pearl Powder, Tourmaline, Hydrolyzed Extensin, Glycerin, Hydrolyzed Pearl, Butylparaben, Ethylparaben, Platinum Powder, Isobutylparaben

    FixerInactive Ingredients: Isododecane, Trimethylsiloxysilicate, Cyclopentasiloxane, DisteardimoniumHectorite, Cyclohexasiloxane, Polyethylene, VP/Eicosene Copolymer, Dextrin Palmitate/Ethylhexanoate, Propylene Carbonate, Propylparaben, Rosa Canina Fruit Oil, Fragrance(Parfum), Polydecene, Squalane, Viscum Album (Mistletoe) Fruit Extract

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  • PURPOSE

    Purpose: Mascara

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  • CAUTION

    CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

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  • KEEP OUT OF REACH OF CHILDREN

    keep it out of children's reach

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  • INSTRUCTIONS

    INSTRUCTIONS: Dual-function mascara that will help scanty and weak eyelashes without smudging.

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  • Directions

    Directions: After curling your lashes, apply fixer first then follow with the mascara. Complete with the fixer again to prevent smudging.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    3CE FIXER AND MASCARA BLACK 
    allantoin liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60764-133
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.006 g  in 6.6 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Isododecane (UNII: A8289P68Y2)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60764-133-02 1 in 1 CARTON 08/20/2016
    1 NDC:60764-133-01 6.6 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/20/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    Name Address ID/FEI Business Operations
    Nanda Co., Ltd 557816075 repack(60764-133)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmax, Inc. 689049693 manufacture(60764-133)
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