Sensodyne Paste, Dentifrice
FDA Label NDC 0135-7753

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 (NDC 0135-7753). 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) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing.
    • 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, cocamidopropyl betaine, xanthan gum, silica, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Questions Or Comments?

1-866-844-2797

Additional Information

ALWAYS FOLOW THE LABEL

SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH

CLINICALLY PROVEN ENAMEL STRENGTHENING

REPAIRS

66%of enamel microdamage in the most vulnerable areas of your teeth^

24/7 PROTECTION

against early stage cavities, sensitivity and future enamel damage**

To help protect teeth for life**

LEAVES YOUR MOUTH

feeling clean and fresh

FRESH MINT

*Vs. your mouth’s natural defenses.

**With twice daily brushing.

^Acid weakened enamel. On average as shown in 7 day lab test.

Principal Display Panel

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PROTECTION

SENSODYNE PRONAMEL

3x STRONGER ENAMEL PROTECTION*

CLINICAL ENAMEL STRENGTH

#1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

FRESH BREATH

NET WT 3.4 OZ (96.4 g)

* Please review the disclaimer below.