Label: SENSITIVE TOOTH PASTE MULTI ACTION- fluoride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-819-57, 59779-819-58 - 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 December 13, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Use
- Uses
- Keep out of reach of children
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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
toothbrush * Brush teeth thoroughly
for at least one minute, preferably
after each meal or at least twice a day
(morning and evening) or as
recommended by a dentist or doctor.
Make sure to brush all sensitive areas
of the teeth.Children under 12
years of age: consult a dentist or doctor. - Inactive ingredients
- PRINCIPAL DISPLAY PANEL
- Warnings
-
INGREDIENTS AND APPEARANCE
SENSITIVE TOOTH PASTE MULTI ACTION
fluoride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-819 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM NITRATE 5.0 g in 100 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.15 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) 24.0 g in 100 g WATER (UNII: 059QF0KO0R) 25.5497 g in 100 g SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.2 g in 100 g SUCRALOSE (UNII: 96K6UQ3ZD4) 0.01 g in 100 g POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) 3.0 g in 100 g FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00034 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 19.0 g in 100 g XANTHAN GUM (UNII: TTV12P4NEE) 0.7 g in 100 g CHONDRUS CRISPUS (UNII: OQS23HUA1X) 0.7 g in 100 g HYDRATED SILICA (UNII: Y6O7T4G8P9) 19.0 g in 100 g SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) 1.0 g in 100 g COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 0.4 g in 100 g ISOPENTANE (UNII: ZH67814I0O) Product Characteristics Color blue (BLUE AND GREEN) Score Shape Size Flavor MINT (Hagelin 622868 Mint Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-819-58 12 in 1 CASE 1 NDC:59779-819-57 121.6 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/13/2011 Labeler - CVS Pharmacy (062312574) Registrant - Lornamead (126440440) Establishment Name Address ID/FEI Business Operations Lornamead 126440440 manufacture Establishment Name Address ID/FEI Business Operations Assured Packaging Inc 248916165 pack
