DR VITA CLINIC GENTLY VITA EXFOLIATOR- glycerin gel

Dr Vita Clinic Gently Vita Exfoliator by

Drug Labeling and Warnings

Dr Vita Clinic Gently Vita Exfoliator by is a Otc medication manufactured, distributed, or labeled by LAB & Company Inc., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DR VITA CLINIC GENTLY VITA EXFOLIATOR 
glycerin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69457-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	Glycerin	9.6 g  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69457-030-02	1 in 1 CARTON	07/01/2016
1	NDC: 69457-030-01	120 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2016

Labeler - LAB & Company Inc. (688284779)

Registrant - LAB & Company Inc. (688284779)

Establishment
Name	Address	ID/FEI	Business Operations
LAB & Company Inc.		688284779	repack(69457-030)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(69457-030)