Label: REPIEL SMART HAIR MASK MAGIC STEAM- 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 29, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Stearyl Alcohol, Behentrimonium Chloride, Amodimethicone, Glycerin, Cetyl Alcohol, Mineral Oil, Methyl Gluceth-20, Dipropylene Glycol, Cetrimonium Chloride, Polysorbate 80, Isopropyl Alcohol, Fragrance, Phenoxyethanol, Panthenol, Citric Acid, Vanillyl Butyl Ether, Disodium EDTA, Hydroxyethylcellulose, Camellia Japonica Seed Oil, Argania Spinosa Kernel Oil, Hydrolyzed Keratin, Portulaca Oleracea Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hydrolyzed Collagen, Soluble Elastin, Chamomilla Recutita (Matricaria) Extract, Aloe Barbadensis Leaf Extract, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium chloride, Magnesium Nitrate

  • PURPOSE

    Purpose: Hair(Scalp) Protectant

  • WARNINGS

    Warnings: For external use only. 1. If the following symptoms arise upon use of the cosmetic product, immediately discontinue use and consult a dermatologist, for continued use may aggravate the symptoms. A. Redness, swelling, itchiness, stimulation, or other symptoms B. Occurrence of the above symptoms upon exposure to direct sunlight. 2. Do not use on areas with wounds, eczema, or dermatitis. 3. Caution for treatment and keeping. A. Keep it out of infants of children's reach. B. Do not store in areas with extreme heat or cold, or under direct sunlight. 4. Avoid the eye area 5. If it gets into your eyes, wash them immediately with cold water. 6. Do not reuse the mask

  • KEEP OUT OF REACH OF CHILDREN

    Keep it out of infants of children's reach.

  • INDICATIONS & USAGE

    Indications & Usage: Provides high nutrients on your hair

    How to use: 1. Wash and cleanse the face to increase the effect of the mask 2. After removing mesh, apply the mask sheet smoothly to your face removing the fabric layer 3. Relax leaving the mask on, After 15~20 minute, peel away mask. Massage gently to maximize the effect of essence * Apply the treatment hair only except the scalp.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Use twice or three times a week.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    REPIEL SMART HAIR MASK MAGIC STEAM 
    dimethicone patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70758-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.6 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70758-040-0210 in 1 CARTON05/01/2016
    1NDC:70758-040-0130 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2016
    Labeler - THE COSRISE CO.,LTD (689840253)
    Registrant - THE COSRISE CO.,LTD (689840253)
    Establishment
    NameAddressID/FEIBusiness Operations
    THE COSRISE CO.,LTD689840253manufacture(70758-040)