Label: ANG EL GLOWR ING HAIR MASK- dimethicone patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 June 16, 2016

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  • ACTIVE INGREDIENT

    Active ingredient: Dimethicone 3.0%

  • INACTIVE INGREDIENT

    Inactive Ingredient: Water, Propylene Glycol, Mineral Oil, Cetearyl Alcohol, Cyclopentasiloxane, Glyceryl Stearate, Steartrimonium Chloride, Panthenol, Dimethiconol, Guar Hydroxypropyltrimonium Chloride, Cyclohexasiloxane, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Vanillyl Butyl Ether, PEG-14M, Mannitol, Cellulose, CI 77492, Hydroxypropyl Methylcellulose, Honey Extract, Royal Jelly Extract, Glycerin, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Phenoxyethanol, Ceramide 3, Sodium Benzoate, Potassium Sorbate, Disodium EDTA, Fragrance

  • PURPOSE

    Purpose: Skin Protectant

  • Warnings

    Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation and/or rash appear. Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Use

    Use: The self-hair pack mask on hair and Remove the hair cap after 15~20 minutes and wash off with lukewarm water.

  • Directions

    Directions: 1. After shampoo, remove excess water from the hair and evenly apply the 1st-step treatment. 2. Wear the hair cap containing the 2nd-step essence and gently massage your head with your fingers. 3. Remove the hair cap after 15~20 minutes and wash off with lukewarm water.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of pouch

  • INGREDIENTS AND APPEARANCE
    ANG EL GLOWR ING HAIR MASK 
    dimethicone patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.6 g  in 20 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-313-0120 g in 1 POUCH; Type 0: Not a Combination Product05/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2016
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798manufacture(59078-313)
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