3CE FIXER AND MASCARA BLACK- allantoin 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.

----------

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.1%

INACTIVE INGREDIENT

Mascara Inactive Ingredients: Water, Acrylates Copolymer, Iron Oxides (CI 77499), Beeswax, Stearic Acid, Butylene Glycol, Acetylated Sucrose Distearate, CoperniciaCerifera (Carnauba) Wax, Alcohol Denat., Triethanolamine, Octylacrylamide/Acrylates/Butylaminoethyl Methacrylate Copolymer, Polysorbate 20, Behenyl Alcohol, Cellulose, Tromethamine, Montmorillonite, Nylon-66, Polyvinyl Alcohol, SorbitanSesquioleate, Phenoxyethanol, Methylparaben, Dimethicone, Propylparaben, Silica, Disodium EDTA, Titanium Dioxide (CI 77891), Potassium Hydroxide, Diamond powder, Polymethylsilsesquioxane, Amethyst Powder, Pearl Powder, Tourmaline, Hydrolyzed Extensin, Glycerin, Hydrolyzed Pearl, Butylparaben, Ethylparaben, Platinum Powder, Isobutylparaben

FixerInactive Ingredients: Isododecane, Trimethylsiloxysilicate, Cyclopentasiloxane, DisteardimoniumHectorite, Cyclohexasiloxane, Polyethylene, VP/Eicosene Copolymer, Dextrin Palmitate/Ethylhexanoate, Propylene Carbonate, Propylparaben, Rosa Canina Fruit Oil, Fragrance(Parfum), Polydecene, Squalane, Viscum Album (Mistletoe) Fruit Extract

PURPOSE

Purpose: Mascara

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: Dual-function mascara that will help scanty and weak eyelashes without smudging.

Directions

Directions: After curling your lashes, apply fixer first then follow with the mascara. Complete with the fixer again to prevent smudging.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

3CE FIXER AND MASCARA BLACK 
allantoin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60764-133
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.006 g  in 6.6 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Isododecane (UNII: A8289P68Y2)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60764-133-02 1 in 1 CARTON 08/20/2016
1 NDC:60764-133-01 6.6 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 08/20/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
Name Address ID/FEI Business Operations
Nanda Co., Ltd 557816075 repack(60764-133)
Establishment
Name Address ID/FEI Business Operations
Cosmax, Inc. 689049693 manufacture(60764-133)

Revised: 10/2016
Document Id: 320228da-ad91-4f88-8a28-459e1c797a76
Set id: 77b4674d-504f-4e02-ae0c-d85c3c06fea5
Version: 1
Effective Time: 20161017
 
Nanda Co., Ltd