DR VITA CLINIC GENTLY VITA EXFOLIATOR- glycerin gel 
LAB & Company Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredient: Glycerin 8.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Quaternium-60, Propylene Glycol, Carbomer, Pentylene Glycol, Fragrance(Parfum), Lactose, Cellulose, Disodium EDTA, Iron Oxides (CI 77492), Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Red 4 (CI 14700), Niacinamide, Ascorbic Acid, Caffeine, Tocopherol, Panthenol, Mannitol, Hippophae Rhamnoides Fruit Extract, Retinol, Polysorbate 20, Caprylic/Capric Triglyceride, Polyglyceryl-10 Diisostearate, Hydrogenated Lecithin, Butylene Glycol, Bromelain, Papain, Menadione, Caprylyl Glycol

PURPOSE

Purpose: Exfoliate Dead Skin (Keratin)

WARNINGS

Warnings: 1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist. 1) In case of having problems such as red spots, swelling, itching or irritation during using this product, 2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight. 2. Do not use it on the part where you have a scar, eczema or dermatitis. 3. For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children.

INDICATIONS & USAGE

Indications & Usage: 1. After face wash & towel dry, apply the exfoliator avoiding eye & lip areas enough to cover entire face. 2. Massage your face in circular movement for about 20-30sec. You can see the dead skin falling out while the formula changes to rubber like gomage. 3. Rinse thoroughly with clean water. Follow with your skin care items.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DR VITA CLINIC GENTLY VITA EXFOLIATOR 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69457-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin9.6 g  in 120 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69457-030-021 in 1 CARTON07/01/2016
1NDC:69457-030-01120 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2016
Labeler - LAB & Company Inc. (688284779)
Registrant - LAB & Company Inc. (688284779)
Establishment
NameAddressID/FEIBusiness Operations
LAB & Company Inc.688284779repack(69457-030)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(69457-030)

Revised: 8/2016
Document Id: df53b772-ee2b-4db7-b618-68812664aeb1
Set id: abecaa63-7520-4070-ad16-469fd330412d
Version: 1
Effective Time: 20160803
 
LAB & Company Inc.