DEARSIR GENTLE RELIEF CLEANSING FO AM- glycerin gel 
Celltrion Skincure 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: Glycerin 25.0%

INACTIVE INGREDIENT

Inactive ingredients: Rosa Centifolia Flower Water, Calamine, Propanediol, Dicaprylyl carbonate, C13-15 Alkane, Squalane, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Water, Caprylyl Methicone, Glycerin, Sodium Chloride, Alcohol, Caprylic/Capric Triglyceride, Orbignya Oleifera Seed Oil, Dimethicone, Disteardimonium Hectorite, Sodium Citrate, Cetyl-PG Hydroxyethyl Palmitamide, PEG-12 Dimethicone/PPG-20 Crosspolymer, Portulaca Oleracea Extract, Phenoxyethanol, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyhydroxystearic Acid, Silica Dimethyl Silylate, Hydrogenated Lecithin, Propylene Carbonate, Polymethylsilsesquioxane, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Lecithin, Polyglyceryl-10 Stearate, Sodium Hyaluronate, Adenosine, Disodium EDTA, Polyglyceryl-3 Polyricinoleate, Xylitylglucoside, Anhydroxylitol, Biosaccharide Gum-1, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Maltodextrin, Helianthus Annuus (Sunflower) Seed Oil, Xylitol, Dipropylene Glycol, Persea Gratissima (Avocado) Fruit Extract, Saccharide Hydrolysate, Pseudoalteromonas Ferment Extract, Sodium Palmitoyl Proline, Crithmum Maritimum Callus Culture Filtrate, Tocopherol, Nymphaea Alba Flower Extract, Phoenix Dactylifera (Date) Seed, Ascorbic Acid, Lupinus Albus Seed Extract, Caprylyl Glycol, Xanthan Gum, Diamond Powder, Ethylhexylglycerin, Leucojum Aestivum Bulb Extract, Acetyl Tetrapeptide-5, Alanine, Proline, Serine, Sodium Phosphate, Sodium Hydroxide

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. If any adverse reaction occurs, stop using the product and consult with the dermatologist if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: - A specially designed cleansing foam for men’s rough and distressed skin from daily aggressors with the mentholated fine beads in the formula for a refreshing finish. - Rich and fine lather removes sebum and pore-clogging impurities from skin with the mild formula.

DOSAGE & ADMINISTRATION

Dosage & Administration: - Apply to wet skin and work into rich lather. - Gently massage all over the face until the lather washes away impurities. - Rinse thoroughly with lukewarm water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DEARSIR GENTLE RELIEF CLEANSING FO AM 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47469-280
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin37.5 g  in 150 mL
Inactive Ingredients
Ingredient NameStrength
Propanediol (UNII: 5965N8W85T)  
Dicaprylyl carbonate (UNII: 609A3V1SUA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47469-280-021 in 1 CARTON07/01/201708/01/2018
1NDC:47469-280-01150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/201708/01/2018
Labeler - Celltrion Skincure Co.,Ltd. (690306386)
Registrant - Celltrion Skincure Co.,Ltd. (690306386)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(47469-280)

Revised: 10/2018
 
Celltrion Skincure Co.,Ltd.