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
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.1%

  • 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

  • PURPOSE

    Purpose: Mascara

  • 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

  • KEEP OUT OF REACH OF CHILDREN

    keep it out of children's reach

  • INSTRUCTIONS

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

  • Directions

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE FIXER AND MASCARA BLACK 
    allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.006 g  in 6.6 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isododecane (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-133-021 in 1 CARTON08/20/2016
    1NDC:60764-133-016.6 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/20/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-133)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-133)