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Smarth Extra Strength Whitening

Dosage form: paste, dentifrice
Ingredients: Sodium monofluorophosphate 7.6mg in 1g
Labeler: Carib Sales, LLC
NDC Code: 60927-118

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.

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
  • 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]

SMARTH   EXTRA STRENGTH WHITENING
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60927-118
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (Fluoride ion) Fluoride ion7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate 
Sorbitol 
Water 
Sodium Pyrophosphate 
Sodium Lauryl Sulfate 
Hydrated Silica 
Sodium Silicate 
Sodium Benzoate 
Saccharin Sodium 
Packaging
#Item CodePackage Description
1NDC:60927-118-131 TUBE 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/FEIOperations
Vikshara Trading & Investment Ltd675920690MANUFACTURE(60927-118)

 
Carib Sales, LLC

Medically reviewed on Oct 8, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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