Sensodyne Pronamel Paste
FDA Label NDC 0135-0810

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 0135-0810). 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 ingredients, 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

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.

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, silica, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Questions Or Comments?

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Principal Display Panel

NEW HALEON

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

PRONAMEL CLINICAL ENAMEL STRENGTH

3X STRONGER ENAMEL PROTECTION*

# 1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

DEEP CLEAN

NET WT 2.3 OZ (65.2 g)

62000000212484 – Front Carton

* Please review the disclaimer below.