CVS PHARMACY  ENAMEL GUARD- fluoride 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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5820164 CVS Sens Enamel Guard Mint

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.

Carton R5

CVS PHARMACY   ENAMEL GUARD
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-815
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
POTASSIUM NITRITE (UNII: 794654G42L) (NITRITE ION - UNII:J39976L608) POTASSIUM NITRITE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-815-491 in 1 CARTON01/07/2013
1NDC:59779-815-42113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/01/2012
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(59779-815) , pack(59779-815)

Revised: 1/2023
Document Id: f32d73d9-90a3-e93b-e053-2995a90a0b47
Set id: 18295a1c-c2a6-489b-be34-9252b9e1e2b8
Version: 5
Effective Time: 20230126
 
CVS Pharmacy