SENSITIVE TOOTH PASTE MULTI ACTION- fluoride gel 
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.

----------

Drug Facts

Active ingredients

POTASSIUM NITRATE 5% .........................................HYPERSENSITIVITY
SODIUM FLUORIDE (0.15% W/V) FLUORIDE ION.........ANTICAVITY

Use

                painful sensitivity of the teeth due to
                cold, heat, acids, sweats or contact

Uses

When using this product if irritation occurs
discontinue use

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

Keep out of reach of children

Keep out of reach of children. If more than

used for brushing is accidentally swallowed, get

medical help  or contact a poison control center

right away

Directions

Adults and children 12 years of age
and older: Apply at least a 1- inch strip
of the prod
uct 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


Inactive ingredients:
Water, Hydrated Silica, Glycerin, Sorbitol, Potassium Nitrate, PEG-6,
Flavor, Isopentane, Xanthan Gum, Chondrus Crispus (Carrageenan),
Sodium Methyl Cocoyl Taurate, Cocomidopropyl Betaine,  Sodium
Saccharin, Sucralose, FD C Blue 1

image of can label


Warnings

Flammable. Contents under pressure.Do not
puncture or incinerate container. Do not store at
temperatures above 120 F. Use only as
directed. Intentional misuse by deliberately
concentrating and inhaling the contents can
be harmful or fatal.

SENSITIVE TOOTH PASTE  MULTI ACTION
fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-819
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM NITRATE5.0 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (BLUE AND GREEN) Score    
ShapeSize
FlavorMINT (Hagelin 622868 Mint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-819-5812 in 1 CASE
1NDC:59779-819-57121.6 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/13/2011
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture
Establishment
NameAddressID/FEIBusiness Operations
Assured Packaging Inc248916165pack

Revised: 12/2011
Document Id: 1029facf-4f3e-4089-b384-0edcccbefb71
Set id: c63e9800-e906-40dc-955e-ea3ca3cf3260
Version: 1
Effective Time: 20111213
 
CVS Pharmacy