Family Wellness Sensitive Extra Whitening
FDA Label NDC 55319-900

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Wellness for the product Family Wellness Sensitive Extra Whitening (NDC 55319-900). 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 ingredients, uses, purpose, warnings, keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

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

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

Uses

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


Purpose

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

Warnings

Stop use and ask a dentist if

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.

Keep Out Of Reach Of Children

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 of the teeth.
Children under 12 years of age Consult a dentist or doctor
Other information Store in a cool, dry place.

Inactive Ingredients

sorbitol, water, silica, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, sodium benzoate, sodium phosphate, tetrasodium pyrophosphate, sodium saccharin.

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