Label: SMILECARE- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69108-001-01 - Packager: Shantou MContinents Trading Co, 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 July 14, 2014
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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INACTIVE INGREDIENT
Inactive Ingredients: Dicalcium Phosphate, Water, Sorbitol, Silica, Glycerin,
Sodium Lauryl Sulfate, Flavor, Sodium Carboxymethyl Cellulose, Titanium Dioxide,
Hydroxypropyl Gum, Sodium Saccharine, Sodium Benzoate, Sodium Phosphate
Decahydrate, Limonene, Contains Sodium Monoflourophosphate: 1.0556ppm
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SMILECARE
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69108-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 64 mg in 8 g Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO) LIMONENE, (+/-)- (UNII: 9MC3I34447) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69108-001-01 8 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/01/2014 Labeler - Shantou MContinents Trading Co, LTD (421359546) Establishment Name Address ID/FEI Business Operations Shantou MContinents Trading Co, LTD 421359546 manufacture(69108-001)