FLUORIDETOOTHPASTE- sodium monofluorophosphate paste, dentifrice 
NEW WORLD HEALTHCARE PRIVATE LIMITED

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-Good morning

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

Warnings

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

Other Information

Inactive Ingredients

Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Sodium Carboxymethyl Cellulose, Flavor, Sodium Saccharin, Sodium Methyl Paraben, Sodium Propyl Paraben

PRINCIPAL DISPLAY PANEL - 43 g Tube Carton

DRUG FACT PANEL

FLUORIDETOOTHPASTE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72423-1073
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72423-1073-643 g in 1 TUBE; Type 0: Not a Combination Product07/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/01/2018
Labeler - NEW WORLD HEALTHCARE PRIVATE LIMITED (873672074)
Establishment
NameAddressID/FEIBusiness Operations
NEW WORLD HEALTHCARE PRIVATE LIMITED873672074manufacture(72423-1073)

Revised: 7/2018
Document Id: 70856d22-cc54-08c7-e053-2991aa0a160c
Set id: 70856d22-cc53-08c7-e053-2991aa0a160c
Version: 1
Effective Time: 20180708
 
NEW WORLD HEALTHCARE PRIVATE LIMITED