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Name:Amar Regular
Manufacturer:Amar Remedies Limited - Mumbai
Category:Over-the-counter (OTC) Marketed Drugs


Amar REGULAR Fluoride Toothpaste

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 older Brush 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 years Use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
Children under 2 years Ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:41499-106
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium monofluorophosphate (Fluoride Ion) Sodium monofluorophosphate 0.76 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
Water  
Silicon Dioxide  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41499-106-01 181 g in 1 TUBE None
2 NDC:41499-106-02 181 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 12/01/2009

Labeler - Amar Remedies Limited - Mumbai (677141751)

Revised: 12/2009 Amar Remedies Limited - Mumbai



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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