Label: MASTIC DENT OULO ACTION- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 15304-4681-1 - Packager: Chia Gi LTD
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 26, 2012
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- Active Ingredients
- Warnings
- Dosage
- Keep out of reach.
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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.
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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
- PURPOSE SECTION
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INGREDIENTS AND APPEARANCE
MASTIC DENT OULO ACTION
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15304-4681 Route of Administration ORAL, DENTAL 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) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K) MENTHOL (UNII: L7T10EIP3A) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) HYDRATED SILICA (UNII: Y6O7T4G8P9) .ALPHA.-BISABOLOL, ()- (UNII: 36HQN158VC) CHAMOMILE (UNII: FGL3685T2X) 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)