REPIEL SMART HAIR MASK MAGIC STEAM- dimethicone patch 
THE COSRISE CO.,LTD

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.

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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

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)

Revised: 6/2016
Document Id: a0fc1f5e-2460-4ae2-9a05-43a25a724d2c
Set id: 0a5108a0-79af-4cc5-a7dc-f82e1080e25d
Version: 1
Effective Time: 20160629
 
THE COSRISE CO.,LTD