SMILECARE  - sodium monofluorophosphate paste, dentifrice 
Shantou MContinents Trading Co, 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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Drug Facts

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: Sodium Monofluorophosphate 0.080 %

Purpose: Anticavity toothpaste

Keep out of reach of children under 6 yrs.

Do not swallow

Directions: Brush your teeth at least twice a day as directed by dentist.

Anticavity toothpaste

copy of label

SMILECARE  
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69108-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION64 mg  in 8 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69108-001-018 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2014
Labeler - Shantou MContinents Trading Co, LTD (421359546)
Establishment
NameAddressID/FEIBusiness Operations
Shantou MContinents Trading Co, LTD421359546manufacture(69108-001)

Revised: 7/2014
Document Id: 26bc01dd-3752-48a4-bb65-a04867b0d414
Set id: bf34b677-1cda-41fe-a9ad-2ea4a6695b73
Version: 1
Effective Time: 20140714
 
Shantou MContinents Trading Co, LTD