AMAR  REGULAR- sodium monofluorophosphate paste, dentifrice 
Amar Remedies Limited - Mumbai

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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Amar
REGULAR
Fluoride Toothpaste

DRUG FACTS

Active ingredient

Sodium monofluorophosphate 0.76% (0.1 w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities.

Warning

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidently swallowed, get medical help or contact a poison control center right away.

Directions

Adults and children 6 years of age and olderBrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician.
Children 2 to 6 yearsUse only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
Children under 2 yearsAsk a dentist or physician.

Inactive Ingredients

Sorbitol, SCMC, Treated Water, Silica, Sodium Lauryl Sulphate, Flavor, Calcium Carbonate, Sodium Saccharine, Sodium Methyl Paraben, Sodium Propyl Paraben.

Distributed by: Amar Remedies Inc.

PRINCIPAL DISPLAY PANEL - 181 g Carton

NEW

Anticavity Fluoride Toothpaste

Amar

FREE TOOTHBRUSH

REGULAR
Toothpaste

Anticavity Fluoride Toothpaste

PRINCIPAL DISPLAY PANEL - 181 g Carton
AMAR   REGULAR
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41499-106
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Sodium monofluorophosphate0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41499-106-01181 g in 1 TUBE
2NDC:41499-106-02181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/2009
Labeler - Amar Remedies Limited - Mumbai (677141751)

Revised: 12/2009
Document Id: 2afb264a-4297-4573-8c55-0d20ca4d62bb
Set id: dd9736d1-4b7b-492e-91be-50182b27d82d
Version: 1
Effective Time: 20091222
 
Amar Remedies Limited - Mumbai