FDA Label for Cvs Pharmacy Pro Defense

View Indications, Usage & Precautions

Cvs Pharmacy Pro Defense Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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.

Active Ingredients



Stannous Fluoride (0.454% w/w)...............................................................Anticavity / Antihypersensitivity


Uses



  • aids in the prevention of dental cavities
  • helps control bleeding gums
  • helps interfere with harmful effects of plaque associated with gingivitis

Warnings



​Stop use and ask a dentist if 

  • gingivitis, bleeding or redness persists for more than 2 weeks
  • if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be signs or symptoms of periodontis, a serious form of gum disease.

Keep Out Of Reach Of Children Under 6 Years Of Age



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


Indications & Usage



Adults and children 2 years of age and older:

  • Brush teeth thoroughly preferably after each meal or at least twice a day and not more than 3 times a day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established.
    • Children under 2 years of age: consult a dentist or doctor


Other Information



  • products containing Stannous Fluoride may cause surface staining of the teeth.  Adequate tooth brushing may prevent these stains which are not harmful or permanent, and may be removed by your dentist.
  • This product is specially formulated to help prevent staining.
  •  Store below 77F (25C)
  • Keep tube capped when not in use.

Inactive Ingredients



glycerin, water, hydrated silica, pentasodium triphosphate, cellulose gum, cocamidopropyl betaine, titanium dioxide, sodium lauryl sulfate, flavor, sodium saccharin


Directions



​Adults and children 2 years of age and older:

Brush teeth thoroughly preferably after each meal or at least twice a day and not more than 3 times a day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.

To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established.

Children under 2 years of age: consult a dentist or doctor


Package Label.Principal Display Panel



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