MASTIC DENT WHITENING- sodium fluoride paste, dentifrice 
Chia Gi 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 Ingredients

Drug Facts:

Active Ingredients:

Warnings

Warnings:

Dosage

Use a pea-sized amount

Keep out of reach.

Keep out of reach of children under 6 years of age.

Directions

Directions:

Inactive Ingredients

Inactive Ingredients:

Water, Sorbitol, Hydrated Silica, Glycerine, Sodium Lauroyl Sarcosinate, Peg-8, Calcium Pyrophosphate, Fragrance, Xanthan Gum, Titanium Dioxide, Chamomilla Recutita, Camelia Sinensis, Menthol Crystals, Sodium Saccharin, Allantoin, Pistacia Lentiscus (Mastic) Gum, Bisabolol, Glycyrrhetinic Acid, Sodium Hydroxide

Information of owner

Product Of Chios

CHIA GI LTD

144 AG. MINA, HIOS, 82100

GREECE
Tel.: 30-22710-33101, FAX: 30-22710-32229
www.masticspa.com
Made In Greece

PURPOSE SECTION

Aids in the prevention of dental cavities-plaque

Image of Label

toothpaste box

MASTIC DENT WHITENING 
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15304-4182
Route of Administration ORAL, DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ENOXOLONE (UNII: P540XA09DR)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALLANTOIN (UNII: 344S277G0Z)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
MENTHOL (UNII: L7T10EIP3A)  
PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
.ALPHA.-BISABOLOL, ()- (UNII: 36HQN158VC)  
CHAMOMILE (UNII: FGL3685T2X)  
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
Product Characteristics
Color white Score     
Shape Size
Flavor MINT (Mint Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:15304-4182-1 75 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 11/22/2005
Labeler - Chia Gi LTD (363215270)
Registrant - Chia Gi LTD (363215270)
Establishment
Name Address ID/FEI Business Operations
Chia Gi LTD 363215270 label(15304-4182) , manufacture(15304-4182) , pack(15304-4182)

Revised: 12/2012
Document Id: 3bf69e68-a5be-40b4-9f36-668ac750e0cd
Set id: 9e98b782-111a-4cf0-98b4-774063a12217
Version: 1
Effective Time: 20121226
 
Chia Gi LTD