AMAR- sodium monofluorophosphate paste, dentifrice

Amar by

Drug Labeling and Warnings

Amar by is a Otc medication manufactured, distributed, or labeled by Amar Remedies Limited - Mumbai. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Distributed by: Amar Remedies Inc.

PRINCIPAL DISPLAY PANEL - 181 g Carton

NEW

Anticavity Fluoride Toothpaste

Amar

FREE TOOTHBRUSH

REGULAR
Toothpaste

Anticavity Fluoride Toothpaste

INGREDIENTS AND APPEARANCE

AMAR   REGULAR
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41499-106
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Sodium monofluorophosphate	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41499-106-01	181 g in 1 TUBE
2	NDC: 41499-106-02	181 g in 1 TUBE

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)