Western Family Sensitive Whitening Fluoride
FDA Label NDC 55312-158

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Western Family Food, Inc. for the product Western Family Sensitive Whitening Fluoride (NDC 55312-158). 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, otc - purpose, otc - keep out of reach of children, use, warnings, directions, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Potassium Nitrate 5%..................Antihypersensitivity

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

Otc - Purpose


Otc - Keep Out Of Reach Of Children


Use

  • 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.

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.


Inactive Ingredients

Sorbitol, Silica, Water, Sodium Lauryl Sulphate, Flavor, Cellulose gum, Titanium Dioxide, Sodium Benzoate, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin

Principal Display Panel

Image Of Container (Wfsensitivewhitening)

Image Of Container (Wfsensitivewhitening)

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