SMARTH EXTRA STRENGTH WHITENING- 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

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

PRINCIPAL DISPLAY PANEL - 181g Tube Carton

SMARTH™

Extra Strength Whitening Fluoride Toothpaste

Extra
WHITENING

NET WT 6.4 Oz [181g]

INGREDIENTS AND APPEARANCE

SMARTH   EXTRA STRENGTH WHITENING
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60927-118
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
Calcium Carbonate (UNII: H0G9379FGK)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Sodium Pyrophosphate (UNII: O352864B8Z)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Hydrated Silica (UNII: Y6O7T4G8P9)
Sodium Silicate (UNII: IJF18F77L3)
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60927-118-13	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(60927-118)