IT RADIANT BRIGHTENING EYE- dimethicone cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
F&CO Co., Ltd.
INN (International Name):
Dimethicone
Composition:
Dimethicone 0.2 mg in 20 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
PURPOSE: Skin Protectant Apply sparingly around eye area with fingertips, using a gentle patting motion.
Authorization status:
OTC monograph final
Authorization number:
69106-270-01

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.

----------

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 10 6 -270

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

Dime thic o ne

0 .2 mg in 20 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Glycerin (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 10 6 -270 -0 1 20 mL in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 3/0 1/20 15

Labeler -

F&CO Co., Ltd. (690166186)

Registrant -

F&CO Co., Ltd. (690166186)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

F&CO Co ., Ltd.

6 9 0 16 6 18 6

re pa c k(6 9 10 6 -270 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

COSMAX INC.

6 8 9 0 19 313

ma nufa c ture (6 9 10 6 -270 )

F&CO Co., Ltd.

Revised: 6/2015

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