Label: 3CE DRAWING LIP CHILLING- lanolin lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 13, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Lanolin 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Mica, Hydrogenated Coco-Glycerides, Red 27 Lake (CI 45410), Red 7 Lake (CI 15850), Rhus Succedanea Fruit Wax, Stearic Acid, Iron Oxides(CI 77499), Triethylhexanoin, Hydrogenated Castor Oil, Acetylated Sucrose Distearate, Microcrystalline Wax, Butylparaben

  • PURPOSE

    Purpose: Lip 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 shows above symptoms when exposed to direct sunlight. 2. Do not use on areas with skin conditions such as open wound, eczema, or any skin disease. 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: Pencil-type lipstick that glides on lips like a crayon.

  • Directions

    Directions: Hold the pencil flat against the lip and apply by tracing your natural lip line, moving towards to fill in.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE DRAWING LIP CHILLING 
    lanolin lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lanolin (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) Lanolin0.02 g  in 1.1 g
    Inactive Ingredients
    Ingredient NameStrength
    Mica (UNII: V8A1AW0880)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-111-021 in 1 CARTON08/01/2016
    1NDC:60764-111-011.1 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075manufacture(60764-111)
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