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CVS Pharmacy Pro Defense

Dosage form: paste, dentifrice
Ingredients: STANNOUS FLUORIDE 0.454g in 100g
Labeler: CVS Pharmacy
NDC Code: 69842-872

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

‚ÄčStop 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.

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

‚ÄčAdults 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

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CVS PHARMACY  PRO DEFENSE
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-872
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION0.454 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
SACCHARIN SODIUM 
WATER 
SODIUM TRIPOLYPHOSPHATE ANHYDROUS 
TITANIUM DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
HYDRATED SILICA 
Cocamidopropyl Betaine 
Sodium Lauryl Sulfate 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-872-191 TUBE in 1 CARTON
1NDC:69842-872-1296.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2017
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
Lornamead126440440manufacture(69842-872), pack(69842-872)

Revised: 10/2017
 
CVS Pharmacy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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