Sensodyne Paste
FDA Label NDC 0135-0579

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 0135-0579). 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, purpose, uses, when using this product,, stop use and ask a dentist if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ When Using This Product,

→ Stop Use And Ask A Dentist If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients

Potassium nitrate 5%**

Sodium fluoride 0.25% (0.16% 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.

When Using This Product,

if irritation occurs discontinue use.

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: Consult a dentist or doctor.

Other Information

store below 30°C (86°F)

Inactive Ingredients

sorbitol, water, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

Questions Or Comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0581-01

SENSODYNE^®

TRUE

white^®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MINT

Sensitivity Relief*

Stain Prevention • Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

FOR SENSITIVE TEETH

NET WT 3.0 OZ (85 g)

Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne^® True White^® has the lowest abrasion formulation ever in a Sensodyne^® toothpaste.

With twice daily brushing it:

is proven to relieve sensitivity pain
helps to gently whiten your teeth
leaves a protective shield to help prevent new stains forming
freshens breath, fights cavities and helps keep gums healthy

*with twice daily brushing

**maximum FDA sensitivity active ingredient

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

ALWAYS FOLLOW THE LABEL

105639XA

NDC 0135-0579-01