Your browser does not support JavaScript! CVS PHARMACY ENAMEL GUARD (FLUORIDE) PASTE, DENTIFRICE [CVS PHARMACY]
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CVS PHARMACY ENAMEL GUARD (fluoride) paste, dentifrice
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-815
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.15 g  in 100 g
POTASSIUM NITRITE (NITRITE ION) POTASSIUM NITRITE5.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
TITANIUM DIOXIDE 
GLYCERIN 
SACCHARIN SODIUM 
WATER 
SODIUM HYDROXIDE 
XANTHAN GUM 
COCAMIDOPROPYL BETAINE 
POLYETHYLENE GLYCOL 400 
HYDRATED SILICA 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-815-491 in 1 CARTON
1NDC:59779-815-42113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/01/2012
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(59779-815), pack(59779-815)

Revised: 1/2013
 
CVS Pharmacy

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