SENSODYNE PRONAMEL GENTLE WHITENING ADVANCED- potassium nitrate and sodium fluoride paste 
Haleon US Holdings LLC

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Drug Facts

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

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

Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

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.

©2021 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

GENTLE WHITENING

ADVANCED

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

NET WT 6.5 OZ (184 g)

62000000069596 Front Carton

Sensodyne Gentle Whitening Advanced 6.5 OZ (184 g)
SENSODYNE PRONAMEL  GENTLE WHITENING ADVANCED
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0580
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0580-011 in 1 CARTON03/15/2021
1184 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0580-024 in 1 CARTON07/01/2023
2184 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02203/15/2021
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 823609e3-48b9-43c6-abb6-05f5365fd60a
Set id: 94e07979-943b-45bb-8e2b-90d686f3692e
Version: 4
Effective Time: 20240304
 
Haleon US Holdings LLC