FDA Label for Sensodyne Pronamel Gentle Whitening Advanced
View Indications, Usage & Precautions
Sensodyne Pronamel Gentle Whitening Advanced Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
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.
Warnings
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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, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide
Questions Or Comments?
1-866-844-2797
Additional Information
ALWAYS FOLLOW THE LABEL
SENSODYNE PRONAMEL
Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.
ACID ATTACKS ENAMEL
WEAKENING THE ENAMEL STRUCTURE
PRONAMEL REBUILDS & RESTORES ENAMEL
FOR STRONG HEALTHY TEETH
Healthy white teeth start with strong enamel.
Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.
With twice-daily brushing, Pronamel helps to:
• Rebuild enamel strength for strong, healthy teeth
• Protect against the effects of dietary acids
• Relieve sensitive teeth
• Freshen breath
• Protect against cavities
Recyclable Carton Save Water
Turn off tap while brushing
Trademarks are owned by or licensed to the GSK group of companies.
©2020 GSK group of companies or its licensor.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
Principal Display Panel
NDC 0135-0580-01
SENSODYNE
PRONAMEL
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
new look with advanced whitening
GENTLE WHITENING
ADVANCED
Specialist Enamel Protection
Rebuilds, Restores, Refreshes
NET WT 6.5 OZ (184 g)
62000000053961 Front Carton
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