SMILECARE- sodium monofluorophosphate paste, dentifrice

smilecare by

Drug Labeling and Warnings

smilecare by is a Otc medication manufactured, distributed, or labeled by Shantou MContinents Trading Co, LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient: Sodium Monofluorophosphate 0.080 %

PURPOSE

Purpose: Anticavity toothpaste

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 yrs.

WARNINGS

Do not swallow

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

Anticavity toothpaste

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMILECARE  
sodium monofluorophosphate paste, dentifrice

Product 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)