Label: FRESHMINT SENSITIVE TOOTHPASTE- fluoride toothpaste paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 68747-6031-1 - Packager: Dabur India Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated August 25, 2008
If you are a consumer or patient please visit this version.
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SPL UNCLASSIFIED SECTION
Drug Facts:
USES
- builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact
- aids in the prevention of dental cavities
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.
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
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.
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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 MintFreshmint 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, dentifriceProduct 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
