FDA Label for Freshmint Anticavity Fluoride Gel Toothpaste

View Indications, Usage & Precautions

Freshmint Anticavity Fluoride Gel Toothpaste Product Label

The following document was submitted to the FDA by the labeler of this product Dabur India Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



NET WT. 6.4 OZ

(181 GRAMS)


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.


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

  • Treated water
  • Sorbitol
  • Carbopol
  • Sodium lauryl sulphate
  • Flavor
  • Polyethylene glycol 1500
  • Sodium saccharin
  • Precipitated Silica
  • Sodium Carboxy Methyl Cellulose
  • Methyl Paraben
  • Propyl Paraben

Package Label.Principal Display Panel



Principal Display Panel

Tube Label

freshmint®

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


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