FRESHMINT SENSITIVE TOOTHPASTE- fluoride toothpaste paste, dentifrice

Freshmint Sensitive Toothpaste by

Drug Labeling and Warnings

Freshmint Sensitive 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

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

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

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

INGREDIENTS AND APPEARANCE

FRESHMINT SENSITIVE TOOTHPASTE 
fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68747-6031
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.4 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM NITRATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68747-6031-1	122 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