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

it Radiant Brightening Sleeping Pack by

Drug Labeling and Warnings

it Radiant Brightening Sleeping Pack 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 SLEEPING PACK- 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 (3.19%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Cyclomethicone, Cetyl Dimethicone, Butylene Glycol, Niacinamide, Betaine, Pentylene Glycol, Trehalose, PEG/PPG-17/6 Copolymer, Cyclopentasiloxane, Phenoxyethanol, Tocopheryl Acetate, Fragrance, Disodium EDTA, Hydrogenated Lecithin, Sucrose Distearate, Ceratonia Siliqua (Carob) Seed Extract, Anthemis Nobilis Flower Water, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Sodium Benzoate, Lilium Candidum Bulb Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Citric Acid, 1,2-Hexandiol, Robinia Pseudoacacia Flower Extract, Benzyl Alcohol, Dehydroacetic 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

Smooth a generous amount of product evenly over entire face and leave on overnight. May be applied after using essence as a daily moisturizer.

DOSAGE & ADMINISTRATION

Smooth a generous amount of product evenly over entire face and leave on overnight. May be applied after using essence as a daily moisturizer.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IT RADIANT BRIGHTENING SLEEPING PACK 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-290
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.95 mg  in 30 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: 69106-290-01	30 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(69106-290)

Revised: 1/2020

Document Id: 6213ac86-1325-4488-aee7-cb381aed5b59

34390-5

Set id: 239058d7-e188-4df7-ae6d-3fcb1ba7b3f9

Version: 2

Effective Time: 20200107

 

F&CO Co., Ltd.