Drug Labeling and Warnings

Drug Details [pdf]

3CE CR EAMY WATER PROOF EYE LINER 08 LES MISERABLES- cyclopentasiloxane liquid 
Nanda Co., Ltd

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: Cyclopentasiloxane 31.4%

INACTIVE INGREDIENT

Inactive Ingredients: Trimethylsiloxysilicate, Mica, Polyethylene, CI 77499(Black Oxide Of Iron), Euphorbia Cerifera (Candelilla) Wax, Titanium Dioxide , Isododecane, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Microcrystalline Wax, CI 77491(Red Oxide of Iron), Synthetic Fluorphlogopite, Calcium Sodium Borosilicate, Beeswax, Iron Oxides, Silica, Polymethyl Methacrylate, DisteardimoniumHectorite, Propylene Carbonate, Butylparaben, BHT

PURPOSE

Purpose: Eye Liner

CAUTION

CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

KEEP OUT OF REACH OF CHILDREN

keep it out of children's reach

INSTRUCTIONS

INSTRUCTIONS: Water Proof eye liner with moisture and oil maintains clear eyes for a long time. This easy-glide eye liner applies smoothly without irritating the eyes.

Directions

Directions: This oil and water resistant eyeliner lasts long while staying put with sharp and defined eye line. The self-sharpening tool can be used to have a sharp eye line.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3CE CR EAMY WATER PROOF EYE LINER 08 LES MISERABLES 
cyclopentasiloxane liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) (CYCLOMETHICONE 5 - UNII:0THT5PCI0R)	CYCLOMETHICONE 5	0.18 g  in 0.6 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60764-043-02	1 in 1 CARTON	08/10/2016	12/01/2018
1	NDC: 60764-043-01	0.6 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/10/2016	12/01/2018

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-043)

Revised: 5/2019

Document Id: 5dc123e8-8d45-4ab4-8a63-57f35216cf48

34390-5

Set id: 95ea3774-25db-4217-9744-675b12286a75

Version: 2

Effective Time: 20190521