FDA Label for Sensodyne Pronamel Mineral Boost Refreshing Peppermint

View Indications, Usage & Precautions

ACTIVE INGREDIENT
PURPOSE
USES
STOP USE AND ASK A DENTIST IF
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS (REFRESHING PEPPERMINT)
INACTIVE INGREDIENTS (WHITENING ACTION)
QUESTIONS OR COMMENTS?
ADDITIONAL INFORMATION
PRINCIPAL DISPLAY PANEL

Sensodyne Pronamel Mineral Boost Refreshing Peppermint 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 Ingredient

Potassium nitrate 5%

Sodium fluoride 0.25% (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.

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

62000000049368

NDC 0135-0480-01