CVS PHARMACY ENAMEL GUARD- sodium fluoride and potassium nitrite paste, dentifrice 
CVS Pharmacy

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.

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Drug Facts

Active ingredients

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

Sodium Fluoride 0.15% w/v fluoride ion...........................................Anticavity

Uses

aids in the prevention of dental caviites

aids in reducing sensitivity

If pain/sensitivity persists after 4 weeks of use, please visit your dentist.

Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. Children under 12 years of age: consult a dentist or doctor

Directions

Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch. Brush teeth thorughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidpropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch.

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Carton label

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Tube Label

CVS PHARMACY  ENAMEL GUARD
fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-815
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.15 g  in 100 g
POTASSIUM NITRITE (UNII: 794654G42L) (NITRITE ION - UNII:J39976L608) POTASSIUM NITRITE 5.0 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
Product Characteristics
Color white Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-815-49 1 in 1 CARTON
1 NDC:59779-815-42 113 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 10/01/2012
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
Name Address ID/FEI Business Operations
Lornamead 126440440 manufacture(59779-815) , pack(59779-815)

Revised: 1/2013
Document Id: dcd32a69-20e3-4016-ba99-50ed18b15de5
Set id: 18295a1c-c2a6-489b-be34-9252b9e1e2b8
Version: 1
Effective Time: 20130107
 
CVS Pharmacy