Freshmint Sensitive Toothpaste
FDA Label NDC 68747-6031

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dabur India Limited for the product Freshmint Sensitive Toothpaste (NDC 68747-6031). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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))

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)

Principal Display Panel (Carton Label)

* Please review the disclaimer below.