Sensodyne Pronamel Paste
FDA Label NDC 0135-0808

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 0135-0808). 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, use, keep out of the reach of children under 6 years of age., directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sodium fluoride 0.254% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

  • aids in the prevention of dental cavities.

Keep Out Of The Reach Of Children Under 6 Years Of Age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 years of age and older:
    • brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and rinsing until good habits are established.
    • children under 2 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, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, blue 1

Questions Or Comments?

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Principal Display Panel

FLUORIDE ANTICAVITY TOOTHPASTE

new HALEON

Sensodyne PRONAMEL

KIDS

Bubble Twist

24hr Cavity Protection*

2x Stronger Enamel Defense*

NET WT 4.0 OZ (113 g)

62000000212226 Carton Front

* Please review the disclaimer below.