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  5. Label Information: Freshmint Sensitive Toothpaste

FDA Label for Freshmint Sensitive Toothpaste

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - WHEN USING
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freshmint Sensitive Toothpaste Product Label

The following document was submitted to the FDA by the labeler of this product Dabur India Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts:

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.


Otc - Active Ingredient



ACTIVE INGREDIENT

Potassium Nitrate - 5 %
Sodium Fluoride - 0.24 %


Otc - Purpose



PURPOSE

Antihypersensitivity
Anticavity


Indications & Usage



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



WARNINGS


Otc - When Using



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.


Dosage & Administration



DIRECTIONS


Inactive Ingredient



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.


Package Label.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

Principal Display Panel- Tube Label - NET WT. 4.3 OZ (122g) - freshmint st 01

Principal Display Panel- Tube Label - NET WT. 4.3 OZ (122g) - freshmint st 01

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


* Please review the disclaimer below.