Active Ingredient
Potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Sensodyne Pronamel Paste
FDA Label NDC 0135-0700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Sensodyne Pronamel (NDC 0135-0700). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purposes, uses, stop use and ask a dentist if, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
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.
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.
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 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
- children under 12 years of age: Consult a dentist or doctor.
Other Information
- do not store above 25°C (77°F)
Inactive Ingredients
water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, xanthan gum, cocamidopropyl betaine, sodium methyl cocoyl taurate, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide
Questions Or Comments?
1-866-844-2797
Additional Information (Fresh Mint)
SENSODYNE PRONAMEL ACTIVE SHIELD
No 1 dentist recommended brand for enamel protection & strengthening.
Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear.
New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.**
Acids from foods, drinks or sugars weaken the enamel surface
Pronamel has a proven formula that actively reinforces weakened enamel
Proven toactively reinforce weakened enamel
Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with:
2X stronger resistance against dietary acids from Day 1*
Helps shield the enamel against erosion and cavities
Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh
*vs your mouth’s natural defenses
** With continued twice daily brushing, a healthy diet and regular dental visits.
#vs Pronamel Daily Protection
ALWAYS FOLLOW THE LABEL
Trademarks owned or licensed by GSK. ©2022 GSK or licensor.
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Additional Information (Cool Mint)
SENSODYNE PRONAMEL ACTIVE SHIELD
No 1 dentist recommended brand for enamel protection & strengthening.
Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear.
New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.**
Acids from foods, drinks or sugars weaken the enamel surface
Pronamel has a proven formula that actively reinforces weakened enamel
Proven toactively reinforce weakened enamel
Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with:
2X stronger resistance against dietary acids from Day 1*
Helps shield the enamel against erosion and cavities
Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh
Effectively and gently removes stains for whiter teeth
*vs your mouth’s natural defenses
** With continued twice daily brushing, a healthy diet and regular dental visits.
#vs Pronamel Daily Protection
ALWAYS FOLLOW THE LABEL
Trademarks owned or licensed by GSK. ©2022 GSK or licensor.
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Principal Display Panel
SENSODYNE
PRONAMEL ACTIVE SHIELD
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
FRESH MINT
Builds Enamel Resistance
For Cavity & Erosion Protection
NET WT 3.4 OZ (96.4 g)
62000000200006 – Front Carton
Sensodyne Pronamel Active Shield Fm 3.4oz_carton (Image 01)
SENSODYNE
PRONAMEL
ACTIVE SHIELD
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
COOL MINT WHITENING
Builds Enamel Resistance
For Cavity & Erosion Protection
NET WT 3.4 OZ (96.4 g)
620000000200004 – Front Carton
Sensodyne Pronamel Active Shield Cm 3.4oz_carton (Image 02)
* Please review the disclaimer below.
