Amar Regular

Dosage form: paste, dentifrice
Ingredients: Sodium monofluorophosphate 0.76g in 100g
Labeler: Amar Remedies Limited - Mumbai
NDC Code: 41499-106

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.

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

AMAR   REGULAR
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41499-106
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (Fluoride Ion) Sodium monofluorophosphate0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Silicon Dioxide 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
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
 
Amar Remedies Limited - Mumbai

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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