SENSODYNE Pronamel iso-active

Dosage form: gel
Ingredients: POTASSIUM NITRATE 50mg in 1g, SODIUM FLUORIDE 1.5mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0518

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%)

Sodium fluoride (0.15 w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses
builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
aids in the prevention of dental cavities

Warnings

When using this product,

if irritation occurs discontinue use.

Stop use and ask a dentist if:
the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
pain/sensitivity still persists after 4 weeks of use, please visit your dentist

Flammable.

Contents under pressure. Do not puncture or incinerate. 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.

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 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 physician. Make sure to brush all sensitive areas of the teeth.
children under 12 years of age: consult a dentist or physician

Inactive ingredients (Daily Protection)

water, sorbitol, hydrated silica, glycerin, PEG-8, isopentane, flavor, cocamidopropyl betaine, sodium methyl cocoyl taurate, xanthan gum, carrageenan, sodium saccharin, sodium hydroxide, blue 1, yellow 10

Inactive ingredients (Gentle Whitening)

water, hydrated silica, sorbitol, glycerin, PEG-8, isopentane, flavor, cocamidopropyl betaine, sodium methyl cocoyl taurate, xanthan gum, carrageenan, sodium saccharin, sodium hydroxide, blue 1

Questions or comments?

call toll-free 1-866-844-2797 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0518-01

SENSODYNE®

PRONAMEL®

DAILY ANTI-CAVITY FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

DAILY PROTECTION

iso-active®

Re-hardens and strengthens enamel.

Protects against the effects of acids in:

FRUIT

SODA

WINE

NET WT 4.3 OZ (121.6g)

9 OUT OF 10 DENTIST RECOMMENDED BRAND

HOW DOES IT WORK?

New Pronamel® iso-active® transforms into a microfine foam during brushing, protecting against the effects of acid erosion by re-hardening your enamel with daily brushing.

SENSODYNE, PRONAMEL, ISO-ACTIVE, and package design elements are registered trademarks of the GlaxoSmithKline group of companies.

Best before: see base of can.

RECYCLING INFORMATION:

Please recycle - when empty.

Does not contain CFCs.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

www.pronamel.com

©2011 GlaxoSmithKline

100810XD

Principal Display Panel

NDC 0135-0519-01

SENSODYNE®

PRONAMEL®

DAILY ANTI-CAVITY FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

GENTLE WHITENING

iso-active®

Re-hardens and strengthens enamel.

Protects against the effects of acids in:

FRUIT

SODA

WINE

NET WT 4.3 OZ (121.6g)

9 OUT OF 10 DENTIST RECOMMENDED BRAND

HOW DOES IT WORK?

New Pronamel® iso-active® transforms into a microfine foam during brushing, protecting against the effects of acid erosion by re-hardening your enamel with daily brushing.

SENSODYNE, PRONAMEL, ISO-ACTIVE, and package design elements are registered trademarks of the GlaxoSmithKline group of companies.

Best before: see base of can.

RECYCLING INFORMATION:

Please recycle - when empty.

Does not contain CFCs.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

www.pronamel.com

©2011 GlaxoSmithKline

100807XD

SENSODYNE  PRONAMEL ISO-ACTIVE
potassium nitrate and sodium fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0518
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
ISOPENTANE 
COCAMIDOPROPYL BETAINE 
SODIUM METHYL COCOYL TAURATE 
XANTHAN GUM 
CARRAGEENAN 
SACCHARIN SODIUM 
SODIUM HYDROXIDE 
FD&C BLUE NO. 1 
D&C YELLOW NO. 10 
Product Characteristics
ColorBLUE (blue and green) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0518-01121.6 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/14/2011
SENSODYNE  PRONAMEL ISO-ACTIVE
potassium nitrate and sodium fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0519
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
ISOPENTANE 
COCAMIDOPROPYL BETAINE 
SODIUM METHYL COCOYL TAURATE 
XANTHAN GUM 
CARRAGEENAN 
SACCHARIN SODIUM 
SODIUM HYDROXIDE 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUE (Blue and Green) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0519-01121.6 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/14/2011
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 02/2014
 
GlaxoSmithKline Consumer Healthcare LP

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.

Hide
(web4)