FRESHMINT SENSITIVE TOOTHPASTE- fluoride toothpaste 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.

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Sensodyne®

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)

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)
FRESHMINT SENSITIVE TOOTHPASTE 
fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-6031
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM NITRATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white) Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68747-6031-1122 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/FEIBusiness Operations
Dabur India Limited650319218MANUFACTURE

Revised: 8/2008
Document Id: 7bbd3de6-b26b-49bf-80e8-717d6b33ed17
Set id: 7bbd3de6-b26b-49bf-80e8-717d6b33ed17
Version: 1
Effective Time: 20080825
 
Dabur India Limited