Your browser does not support JavaScript! MASTIC DENT OULO ACTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHIA GI LTD]
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MASTIC DENT OULO ACTION (sodium fluoride) paste, dentifrice
[Chia Gi LTD]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredients

Drug Facts:

Active Ingredients:

  • Sodium Fluoride 0.22% (0.12% w/v fluoride ion) - Anticavity

Warnings

Warnings:

  • When using this product, if irritation occurs discontinue use.
  • Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a poison control Center right away.

Dosage

Use a pea-sized amount

Keep out of reach.

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

Directions

Directions:

  • Adults and children 2 years and older.
  • Brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
  • Instruct in good brushing and rinsing habits (to minimize swallowing).
  • ​Children under 2 years​ do not use unless directed by a dentist or a physician.

Inactive Ingredients

Inactive Ingredients:

Water, Sorbitol, Hydrated Silica, Glycerine, Peg-8, Fragrance, Sodium Lauryl Sarcosinate, 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

Image of Label

toothpaste box

MASTIC DENT OULO ACTION 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:15304-4681
Route of AdministrationORAL, DENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ENOXOLONE 
POLYETHYLENE GLYCOL 400 
SODIUM HYDROXIDE 
ALLANTOIN 
SORBITOL 
GLYCERIN 
SODIUM LAUROYL SARCOSINATE 
SACCHARIN SODIUM 
TITANIUM DIOXIDE 
XANTHAN GUM 
CAMELLIA SINENSIS SEED OIL 
MENTHOL 
PISTACIA LENTISCUS RESIN 
HYDRATED SILICA 
.ALPHA.-BISABOLOL, ()- 
CHAMOMILE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Mint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15304-4681-175 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/22/2005
Labeler - Chia Gi LTD (363215270)
Registrant - Chia Gi LTD (363215270)
Establishment
NameAddressID/FEIBusiness Operations
Chia Gi LTD363215270manufacture(15304-4681), label(15304-4681), pack(15304-4681)

Revised: 12/2012
 
Chia Gi LTD

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