it Radiant Brightening Eye by F&CO Co., Ltd. / COSMAX INC.

it Radiant Brightening Eye by

Drug Labeling and Warnings

it Radiant Brightening Eye by is a Otc medication manufactured, distributed, or labeled by F&CO Co., Ltd., COSMAX INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IT RADIANT BRIGHTENING EYE- dimethicone cream 
F&CO 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 (1.0%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Glycerin, Cyclopentasiloxane, Butylene Glycol, Niacinamide, PEG/PPG-17/6 Copolymer, Ethylhexyl Palmitate, 1,2-Hexandiol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-20 Methyl Glucose Sesquistearate, Carbomer, Tromethamine, Titanium Dioxide (CI 77891), Phexnoyethanol, Cetearyl Alcohol, Polysorbate 60, Dimethiconol, Mica (CI 77019), Fragrance, Xanthan Gum, Caprylyl Glycol, Silica, Dipotassium Glycyrrhizate, Ethylhexylglcerin, Calcium Aluminum Borosilicate, Disodium EDTA, Anthemis Nobilis Flower Water, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Nelumbo Nucifera Flower Extract, JAsminum Officinale (Jasmine) Flower/Leaf Extract, Lilium Candidum Bulb Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Rose Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Tin Oxide (CI 77861), Ceratonia Siliqua (Carob) Seed Extract, Robinia Pseudoacacia Flower Extract, Benzyl Alcohol, Sodium Benzoate, Dehydroacetic Acid, Citric Acid

PURPOSE

PURPOSE: Skin Protectant

WARNINGS

WARNINGS: If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Apply sparingly around eye area with fingertips, using a gentle patting motion.

DOSAGE & ADMINISTRATION

Apply sparingly around eye area with fingertips, using a gentle patting motion.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IT RADIANT BRIGHTENING EYE 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-270
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.2 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-270-01	20 mL in 1 CARTON; Type 0: Not a Combination Product	03/01/2015	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2015	11/01/2019

Labeler - F&CO Co., Ltd. (690166186)

Registrant - F&CO Co., Ltd. (690166186)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(69106-270)

Revised: 1/2020

Document Id: 4eb7b65d-0f76-42ee-9ab9-c2367f4cb3dc

34390-5

Set id: 04c19d15-5aea-4e57-8e8b-6ac37ed99c20

Version: 2

Effective Time: 20200107

 

F&CO Co., Ltd.