Label: CVS PHARMACY ENAMEL GUARD- fluoride paste, dentifrice
- NDC Code(s): 59779-815-42, 59779-815-49
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated January 26, 2023
If you are a consumer or patient please visit this version.
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- Active ingredients
- Uses
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WARNINGS
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.
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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
- Inactive ingredients
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CVS PHARMACY ENAMEL GUARD
fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-815 Route of Administration DENTAL 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 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 01/07/2013 1 NDC:59779-815-42 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/01/2012 Labeler - CVS Pharmacy (062312574) Registrant - Lornamead (080046418) Establishment Name Address ID/FEI Business Operations Lornamead 080046418 manufacture(59779-815) , pack(59779-815)