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Package Insert and Label Information: Freshmint Anticavity Fluoride Gel Toothpaste

By Dabur India Limited | Last revised: 25 August 2008

FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE- sodium fluoride paste, dentifrice
Dabur India Limited

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.

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)

Tube Label Tube Tube Label Tube
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.2 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
SORBITOL
CARBOMER HOMOPOLYMER TYPE C
SODIUM LAURYL SULFATE
POLYETHYLENE GLYCOL 1500
SACCHARIN SODIUM
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM
METHYLPARABEN
PROPYLPARABEN
Product Characteristics
Color Score
Shape Size
Flavor MINT (MINT) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68747-6027-1 181 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 08/25/2009
Labeler — Dabur India Limited (650319218)
Establishment
Name Address ID/FEI Operations
Dabur India Limited 650319218 MANUFACTURE

Revised: 08/2008 Dabur India Limited

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