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SMARTH

Carib Sales, LLC
Vikshara Trading & Investment Ltd

SMARTH™ Extra Strength Fluoride Toothpaste REGULAR


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

AntiCavity Toothpaste

Use

aids in the prevention of dental cavities

Warning

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

  • Do not swallow
  • Supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
  • Children under 6 years of age: Do not use unless directed by a doctor or dentist

Inactive Ingredients

Calcium Carbonate, Sorbitol, Demineralized Water, Sodium Lauryl Sulphate, Hydrated Silica, Sod. CMC, Flavor, Sodium Silicate, Sodium Benzoate, Sodium Saccharin

PRINCIPAL DISPLAY PANEL - 181g Tube Carton

SMARTH™

Extra Strength Fluoride Toothpaste

REGULAR

NET WT 6.4 Oz [181g]

SMARTH

SMARTH

SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:60927-117
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION 7.6 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM CARBONATE
sorbitol
water
SODIUM LAURYL SULFATE
HYDRATED SILICA
SODIUM SILICATE
SODIUM BENZOATE
saccharin sodium

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 181 in 1 TUBE
2 NDC:60927-117-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2013-12-01


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