Walgreens Maximum Strength Sensitive Fluoride
FDA Label NDC 0363-0631

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Maximum Strength Sensitive Fluoride (NDC 0363-0631). 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 active ingredient, warnings, directions, use, inactive ingredients, otc - purpose, otc - keep out of reach of children, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Potassium nitrate 5%........................................... Antihypersensitivity

Sodium Fluoride 0.243% (0.15% w/v fluoride ion).... Anticavity toothpaste

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 problems 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 that used for brushing seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children     Brush teeth for at least one minute, preferably after 12 years and older      each meal, or at least twice a day or as directed by                                   your dentist. Be sure to brush sensitive areas.Children under           Consult a dentist or doctor 12 years of age             Other information        Store in a cool, dry place.

Use

  • Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact
  • Aids in the prevention of dental cavities

Inactive Ingredients

Sorbitol,Water, Silica, Sodium Lauryl Sulphate, Flavor, Cellulose Gum,Titanium Dioxide, Sodium Benzoate, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin, FDC Blue No. 1, DC Yellow No.10

Otc - Purpose


Otc - Keep Out Of Reach Of Children


* Please review the disclaimer below.