Label: 3CE SUPER SLIM PEN EYE LINER BROWN- butylene glycol liquid

  • 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 September 21, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Butylene Glycol 6.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Styrene/Acrylates Copolymer, Alcohol Denat., Ceteth-20, Yellow 5 (CI 19140), Laureth-25, Red 33 (CI 17200), Diethylhexyl Sodium Sulfosuccinate, Phenoxyethanol, Blue 1 (CI 42090), Methylparaben, Propylparaben, Ethylparaben, Glycerin, Diamond powder, Pearl Powder, Polysorbate 80, Platinum Powder

  • PURPOSE

    Purpose: Eye Liner

  • 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: Liquid eyeliner that allows endless vivid drawing. Soft, smudge-proof and easily-washable type eyeliner creates perfectly defined eyes without irritating skin around the eyes

  • Directions

    Directions: Line along the upper lash line following the contour of the eye. Flare outward for more drama or create your own unique design.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE SUPER SLIM PEN EYE LINER BROWN 
    butylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Butylene Glycol (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA) Butylene Glycol0.05 g  in 0.9 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ceteth-20 (UNII: I835H2IHHX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-018-021 in 1 CARTON08/10/2016
    1NDC:60764-018-010.9 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/10/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-018)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-018)