Drug Details [pdf]

3CE CR EAMY WATER PROOF EYE LINER 13 CAFFEINE- 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 34.5%

INACTIVE INGREDIENT

Inactive Ingredients: Trimethylsiloxysilicate, CI 77499 (Black Oxide Of Iron), Polyethylene, Euphorbia Cerifera (Candelilla) Wax, Isododecane, CI 77492 (Yellow Oxide Of Iron), CI 77491 (Red Oxide of Iron), Microcrystalline wax, Nylon-12, Beeswax, CI 15880:1(Red 34 Lake), DisteardimoniumHectorite, Propylene Carbonate, Sorbitansesquioleate, 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

Image of carton

3CE CR EAMY WATER PROOF EYE LINER 13 CAFFEINE
cyclopentasiloxane liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-042
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) (CYCLOMETHICONE 5 - UNII:0THT5PCI0R)	CYCLOMETHICONE 5	0.20 g in 0.6 g

Ingredient Name	Strength
Inactive Ingredients
Isododecane (UNII: A8289P68Y2)
Propylene Carbonate (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 60764-042-02	1 in 1 CARTON	08/10/2016	12/01/2018
1	NDC: 60764-042-01	0.6 g in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(60764-042)

Revised: 5/2019

Document Id: 463e511c-2b26-4a7c-ac43-3ac262581a08

Set id: 8af8def9-7a94-4e4f-892d-75f8afca4d01

Version: 2

Effective Time: 20190521

Drug Labeling and Warnings