Active Ingredient
Potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Sensodyne Pronamel Paste
FDA Label NDC 0135-0450
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 0135-0450). 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, purpose, uses, stop use and ask a dentist if, keep out of reach of children., directions, other information, inactive ingredients (refreshing peppermint), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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 (Refreshing Peppermint)
water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin
Inactive Ingredients (Whitening Action)
water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide
Questions Or Comments?
1-866-844-2797
Additional Information
Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide
Minerals keep enamel strong and white. But acidic foods & drinks can dissolve surface minerals. Your saliva naturally replenishes minerals but can’t always keep up, leading to enamel loss.
Pronamel Mineral Boost improves natural mineral absorption for strong white teeth, protected from sensitivity.
ACIDS DISSOLVE SURFACE MINERALS…
…PRONAMEL BOOSTS MINERAL ABSORPTION FROM SALIVA
Replenishes vital minerals in enamel.
Developed to maximize the effect of fluoride to boost the absorption of calcium & phosphate into the enamel surface.
With twice-daily brushing, Pronamel helps to:
- Protect against effects of dietary acids
- Prevent enamel loss
- Relieve sensitive teeth
- Protect against cavities
- Clean and freshen your mouth
Recyclable Carton
Save Water
Turn off tap while brushing
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
Principal Display Panel
NDC 0135-0450-01
SENSODYNE
PRONAMEL
MINERAL BOOST
new
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
Replenishes Vital Minerals
For Stronger, Healthier Enamel
infused with refreshing peppermint
NET WT 4.0 OZ (113g)
gsk
©2020 GSK group of companies or its licensor.
62000000049368
NDC 0135-0480-01
SENSODYNE
PRONAMEL
MINERAL BOOST
new
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
Replenishes Vital Minerals
For Stronger, Healthier Enamel
With gentle whitening action
NET WT 4.0 OZ (113g)
gsk
©2020 GSK group of companies or its licensor.
62000000049369
* Please review the disclaimer below.
