Sensitive Tooth Paste Whitening

Dosage form: gel
Ingredients: POTASSIUM NITRATE 5.0g in 100g, SODIUM FLUORIDE 0.15g in 100g
Labeler: CVS Pharmacy
NDC Code: 59779-816

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

Use
  •  builds increasing protection against
                painful sensitivity of the teeth due to
                cold, heat, acids, sweats or contact
  •  aids in the prevention of dental cavities

UsesWhen 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, Sodium Tripolyphosphate,
PEG-6, Flavor, Isopentane, Xanthan Gum, Chondrus Crispus (Carrageenan),
Sodium Hydroxide, Sodium Methyl Cocoyl Taurate, Cocomidopropyl Betaine,
Sodium Saccharin, Sucralose, FD C Blue 1


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  WHITENING
fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-816
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (POTASSIUM CATION) POTASSIUM NITRATE5.0 g  in 100 g
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL24.0 g  in 100 g
WATER22.0697 g  in 100 g
SACCHARIN SODIUM0.2 g  in 100 g
SUCRALOSE0.01 g  in 100 g
POLYETHYLENE GLYCOL 3003.0 g  in 100 g
FD&C BLUE NO. 10.0003 g  in 100 g
GLYCERIN19.0 g  in 100 g
XANTHAN GUM0.7 g  in 100 g
CHONDRUS CRISPUS0.7 g  in 100 g
HYDRATED SILICA19.0 g  in 100 g
SODIUM METHYL COCOYL TAURATE1.0 g  in 100 g
COCAMIDOPROPYL BETAINE0.4 g  in 100 g
ISOPENTANE 
SODIUM HYDROXIDE0.48 g  in 100 g
SODIUM TRIPOLYPHOSPHATE 
Product Characteristics
Colorblue (BLUE AND GREEN) Score    
ShapeSize
FlavorMINT (Hagelin 673902 Mint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-816-6812 CAN (CAN) in 1 CASE
1NDC:59779-816-67121.6 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/FEIOperations
Lornamead126440440manufacture
Establishment
NameAddressID/FEIOperations
Assured Packaging Inc248916165pack

Revised: 12/2011
 
CVS Pharmacy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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