Freshmint Anticavity Fluoride Gel Toothpaste

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 2.2mg in 1g
Labeler: Dabur India Limited
NDC Code: 68747-6027

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.

FRESHMINT®
ANTICAVITY FLUORIDE GEL TOOTHPASTE

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

Tube Label

freshmint®

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

FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE 
fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6027
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
CARBOMER HOMOPOLYMER TYPE C 
SODIUM LAURYL SULFATE 
POLYETHYLENE GLYCOL 1500 
SACCHARIN SODIUM 
SILICON DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
METHYLPARABEN 
PROPYLPARABEN 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68747-6027-1181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/25/2009
Labeler - Dabur India Limited (650319218)
Establishment
NameAddressID/FEIOperations
Dabur India Limited650319218MANUFACTURE

Revised: 08/2008
 
Dabur India Limited

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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