SMARTH  EXTRA STRENGTH WHITENING- sodium monofluorophosphate paste, dentifrice 
Carib Sales, LLC

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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Smarth™
Extra Strength Whitening

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

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]

Principal Display Panel - 181g Tube Carton
SMARTH   EXTRA STRENGTH WHITENING
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60927-118
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride ion - UNII:Q80VPU408O) Fluoride ion7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60927-118-131 in 1 CARTON
1181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/2013
Labeler - Carib Sales, LLC (081234528)
Registrant - Vikshara Trading & Investment Ltd (675920690)
Establishment
NameAddressID/FEIBusiness Operations
Vikshara Trading & Investment Ltd675920690MANUFACTURE(60927-118)

Revised: 10/2013
Document Id: 055490e3-e4be-45d5-a1cf-c30a06ba8c42
Set id: 89161fe7-fd11-4ff4-a2f0-381c59c1ff55
Version: 1
Effective Time: 20131008
 
Carib Sales, LLC