Sensodyne Paste
FDA Label NDC 0135-5022

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 0135-5022). 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, 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 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.

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 specially formulated to help prevent staining.
  • do not store above 25°C (77°F)

Inactive Ingredients

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

Questions Or Comments?

1-866-844-2797

Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE

SENSITIVITY
GUM &
ENAMEL

Gum recession and enamel wear are the two leading causes of sensitive teeth. Gum problems are caused by a build-up of plaque bacteria along the gum line. Enamel wear can be caused by acids in

everyday foods and drinks.

Sensodyne Sensitivity, Gum & Enamel is a daily toothpaste with a clinically proven ingredient to relieve sensitive teeth and improve gum health, while also strengthening the enamel.

1. Builds a protective layer over the sensitive areas
2. Formula with stannous fluoride targets & removes plaque bacteria** in between teeth & gumline.
3. Strengthens enamel surface and protects teeth from acids, while being gentle on enamel.

*with twice daily brushing.
**plaque bacteria associated with gingivitis to help reduce swollen, bleeding gums.

Trademarks owned or licensed by GSK. @2022 GSK or licensor.

Distributed by: GSK Consumer Healthcare
Warren, NJ 07059. Made in Germany

CARTON
RECYCLE

Principal Display Panel

new

#1 Dentist RecommendED Brand

SENSODYNE

MINT
SENSITIVITY GUM & ENAMEL

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH,
ANTI-GINGIVITIS AND CAVITY PREVENTION

NEW WT 3.4 OZ (96.4 g)

20041 Front Carton


Sensodyne Sensitivity Gum & Enamel Mint 3.4 Oz Carton (Image 01)

Sensodyne Sensitivity Gum & Enamel Mint 3.4 Oz Carton (Image 01)

* Please review the disclaimer below.