Sensodyne Paste
FDA Label NDC 0135-5023

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 0135-5023). 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, purposes, 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 Ingredient

→ Purposes

→ Uses

→ When Using This Product,

→ Stop Use And Ask A Dentist If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients (sensitivity & Gum Whitening)

→ Inactive Ingredients (sensitivity & Gum Mint)

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, Antigingivitis, Antihypersensitivity

Uses

aids in the prevention of dental cavities.
helps control bleeding gums.
Helps interfere with harmful effects of plaque associated with gingivitis.
builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

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.
gingivitis, bleeding, or redness persists for more than 2 weeks.
you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These maybe signs or symptoms of periodontitis, a serious form of gum disease.

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

products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
this product is specifically formulated to help prevent staining.
store below 25°C (77°F)

Inactive Ingredients (Sensitivity & Gum Whitening)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Inactive Ingredients (Sensitivity & Gum Mint)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Questions Or Comments?

1-866-844-2797

Principal Display Panel

NDC 0135-5024-01

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SENSODYNE

WITH FLUORIDE

SENSITIVITY & GUM

IMPROVES GUM HEALTH

WHITENING

LOW ABRASION FORMULA

DUAL ACTION TOOTHPASTE

TOOTHPASTE FOR SENSITIVE TEETH, GINGIVITIS AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4g)

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Sensitivity & Gum?

Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity & improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.

SENSITIVE AREAS AND SWOLLEN BLEEDING GUMS

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS

TARGETS & HELPS REMOVE PLAQUE BACTERIA

RELIEVES TOOTH SENSITIVITY* & IMPROVES GUM HEALTH

*with twice daily brushing

Dual Action forTOOTH SENSITIVITY & GUM PROBLEMS

ALWAYS FOLLOW THE LABEL

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

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

62000000039060

NDC 0135-5023-01

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