SMARTH EXTRA STRENGTH BAKING SODA- sodium monofluorophosphate paste, dentifrice

Smarth by

Drug Labeling and Warnings

Smarth by is a Otc medication manufactured, distributed, or labeled by Carib Sales, LLC, Vikshara Trading & Investment Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Sorbitol, Hydrated Silica, Demineralized Water, Sodium Lauryl Sulphate, Sodium Bicarbonate, Sod. CMC, Flavor, Sodium Benzoate, Sodium Saccharin

PRINCIPAL DISPLAY PANEL - 181g Tube Carton

SMARTH™

Extra Strength Fluoride Toothpaste

BAKING SODA

NET WT 6.4 Oz [181g]

INGREDIENTS AND APPEARANCE

SMARTH   EXTRA STRENGTH BAKING SODA
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60927-115
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride ion - UNII:Q80VPU408O)	Fluoride ion	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Water (UNII: 059QF0KO0R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Sodium Bicarbonate (UNII: 8MDF5V39QO)
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)
Carboxymethylcellulose Sodium (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60927-115-10	1 in 1 CARTON
1		181 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/01/2013

Labeler - Carib Sales, LLC (081234528)

Registrant - Vikshara Trading & Investment Ltd (675920690)

Establishment
Name	Address	ID/FEI	Business Operations
Vikshara Trading & Investment Ltd		675920690	MANUFACTURE(60927-115)