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Package Insert and Label Information: Freshmint Sensitive Toothpaste

By Dabur India Limited | Last revised: 25 August 2008

FRESHMINT SENSITIVE TOOTHPASTE- sodium fluoride and potassium nitrate 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.

Drug Facts:

ACTIVE INGREDIENT

Potassium Nitrate — 5 %
Sodium Fluoride — 0.24 %

PURPOSE

Antihypersensitivity
Anticavity

USES

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities

WARNINGS

When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor.

Stop and ask a dentist if problem persists or worsens. Sensitive teeth may indicate a serious problem that may require prompt care by a dentist. Keep out of reach of children.

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

DIRECTIONS

Adults and children 12 years and older

Brush teeth for at least one minute, preferably after each meal, or at least twice a day, or as directed by your dentist. Be sure to brush sensitive areas

Children under 12 years of age

Consult a dentist or doctor.

Other information

Store In a cool dry place.

INACTIVE INGREDIENTS: Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulphate, Glycerin, Flavor, Sodium Carboxy Methyl Cellulose, Titanium Dioxide, Tri Sodium Ortho Phosphate, Sodium Saccharin, Sodium Benzoate, Methyl Paraben, Propyl Paraben, Color D & C Yellow # 10, FD & C Blue # 1.

Principal Display Panel — NET WT. 4.3 OZ (122g)

Freshmint Sensitive Toothpaste Tube Label
freshmint ®

Sensitive Toothpaste NET WT. 4.3 OZ (122g)

Anti-cavity Fluoride Tootpaste for Sensitive
*Compare to the Active Ingredients of Sensodyne® Fresh Mint

Principal Display Panel- Tube Label -- NET WT. 4.3 OZ (122g)
(click image for full-size original)

Freshmint Sensitive Toothpaste Carton Label
freshmint ®

Sensitive Toothpaste NET WT. 4.3 OZ (122g)

Anti-cavity Fluoride Tootpaste for Sensitive
*Compare to the Active Ingredients of Sensodyne® Fresh Mint

Principal Display Panel -- Carton Label -- NET WT. 4.3 OZ (122g)
(click image for full-size original)
FRESHMINT SENSITIVE TOOTHPASTE
fluoride toothpaste paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68747-6031
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.4 mg in 1 g
POTASSIUM NITRATE (POTASSIUM CATION) POTASSIUM NITRATE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL
SILICON DIOXIDE
WATER
POLYETHYLENE GLYCOL 1500
SODIUM LAURYL SULFATE
GLYCERIN
CARBOXYMETHYLCELLULOSE SODIUM
TITANIUM DIOXIDE
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE
SACCHARIN SODIUM
SODIUM BENZOATE
METHYLPARABEN
PROPYLPARABEN
Product Characteristics
Color white (white) Score
Shape Size
Flavor MINT (MINT) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68747-6031-1 122 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