FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE- fluoride toothpaste paste, dentifrice

Freshmint Anticavity Fluoride Gel Toothpaste by

Drug Labeling and Warnings

Freshmint Anticavity Fluoride Gel Toothpaste by is a Otc medication manufactured, distributed, or labeled by Dabur India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NET WT. 6.4 OZ

(181 GRAMS)

DRUG FACTS:

ACTIVE INGREDIENT

Sodium fluoride - 0.22% (0.1% w/v fluoride ion)

PURPOSE

Anticavity.

USE

Helps protect against cavities.

WARNINGS

Keep out of 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 right away.

DIRECTIONS:

Adults & Children 6 years of age & older:

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or 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

Treated Water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Poly Ethylene Glycol 1500, Sodium Saccharin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Methyl Paraben, Propyl Paraben.

Product of India
Exclusive Distributor
New World Imports, Inc.
160 Athens Way
Nashville, TN 37228.

Expires: 3 years from the Date of Mfg.

C. No. DNH/COS/DNH/52Mfg.
Date & Batch No. on crimp.

24.06.2009
FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE

ACTIVE INGREDIENT: SODIUM FLUORIDE - 0.22 %
(0.1% w/v fluoride Ion)

SR. NO. INGREDIENTS

1. Treated water
2. Sorbitol
3. Carbopol
4. Sodium lauryl sulphate
5. Flavor
6. Polyethylene glycol 1500
7. Sodium saccharin
8. Precipitated Silica
9. Sodium Carboxy Methyl Cellulose
10. Methyl Paraben
11. Propyl Paraben

PRINCIPAL DISPLAY PANEL

Principal Display Panel

Tube Label

freshmint®

ANTICAVITY FLUORIDE GEL TOOTHPASTE
NET WT. 6.4 OZ
(181 GRAMS)

INGREDIENTS AND APPEARANCE

FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE 
fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68747-6027
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68747-6027-1	181 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/25/2009

Labeler - Dabur India Limited (650319218)

Establishment
Name	Address	ID/FEI	Business Operations
Dabur India Limited		650319218	MANUFACTURE