Label: MASTIC DENT OULO ACTION- sodium fluoride paste, dentifrice
- NDC Code(s): 15304-4681-1
- Packager: Chia Gi LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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
- Sodium Fluoride 0.22% (0.12% w/v fluoride ion) - Anticavity
- 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.
Use a pea-sized amountClose
- Keep out of reach.
Keep out of reach of children under 6 years of age.Close
- 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
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 HydroxideClose
- Information of owner
Product Of Chios
CHIA GI LTD
144 AG. MINA, HIOS, 82100GREECE
Tel.: 30-22710-33101, FAX: 30-22710-32229
Made In Greece
- PURPOSE SECTION
Aids in the prevention of dental cavitiesClose
- Image of Label
- INGREDIENTS AND APPEARANCE
MASTIC DENT OULO ACTION
sodium fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:15304-4681 Route of Administration ORAL, DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 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:15304-4681-1 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 manufacture(15304-4681), label(15304-4681), pack(15304-4681)