3CE FIXER AND MASCARA BROWN- 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.

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ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.1%

INACTIVE INGREDIENT

Mascara Inactive Ingredients: Water, Acrylates Copolymer, Beeswax, Stearic Acid, Iron Oxides (CI 77499), Butylene Glycol, Acetylated Sucrose Distearate, CoperniciaCerifera (Carnauba) Wax, Alcohol Denat., Triethanolamine, Octylacrylamide/Acrylates/Butylaminoethyl Methacrylate Copolymer, Iron Oxides (CI 77491), Titanium Dioxide (CI 77891), Polysorbate 20, Behenyl Alcohol, Cellulose, Iron Oxides (CI 77492), Tromethamine, Montmorillonite, Nylon-66, Polyvinyl Alcohol, SorbitanSesquioleate, Phenoxyethanol, Methylparaben, Dimethicone, Propylparaben, Silica, Disodium EDTA, Potassium Hydroxide, Diamond powder, Polymethylsilsesquioxane, Amethyst Powder, Pearl Powder, Tourmaline, Hydrolyzed Extensin, Glycerin, Hydrolyzed Pearl, Butylparaben, Ethylparaben, Platinum Powder, Isobutylparaben

Fixer Inactive 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 BROWN 
allantoin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-134
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.006 g  in 6.6 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Isododecane (UNII: A8289P68Y2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-134-021 in 1 CARTON08/20/2016
1NDC:60764-134-016.6 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/20/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075repack(60764-134)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-134)

Revised: 10/2016
Document Id: a0f8a295-ea3e-4c1d-bb41-1be19b835afd
Set id: 3b33e66d-dcca-459a-b1f2-6318015fe1c2
Version: 1
Effective Time: 20161017
 
Nanda Co., Ltd