SENSODYNE Sensitivity and Gum Mint 1.1 mg/g

stannous fluoride · PASTE · Haleon US Holdings LLC

No Recall History

Plain English

SENSODYNE Sensitivity and Gum Mint is a paste containing stannous fluoride at 1.1 mg/g, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name: SENSODYNE Sensitivity and Gum Mint
Generic Name: stannous fluoride
NDC Code (Product): 0135-5023
Manufacturer: Haleon US Holdings LLC
Strength: 1.1 mg/g
Dosage Form: PASTE
Route: ORAL
Marketing Status
Application #: M022
Marketing Start: 01/06/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective44 reports

oral discomfort40 reports

oral pain18 reports

condition aggravated15 reports

hyperaesthesia teeth15 reports

toothache13 reports

stomatitis12 reports

hypersensitivity10 reports

lip swelling9 reports

oral mucosal exfoliation9 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & Administration

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.

Warnings

Warnings 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.

Frequently Asked Questions

What is SENSODYNE Sensitivity and Gum Mint used for?

SENSODYNE Sensitivity and Gum Mint contains stannous fluoride. It is a paste taken oral. Consult your doctor for specific uses.

Is SENSODYNE Sensitivity and Gum Mint a controlled substance?

SENSODYNE Sensitivity and Gum Mint is not classified as a controlled substance by the DEA.

What is the generic name for SENSODYNE Sensitivity and Gum Mint?

The generic name for SENSODYNE Sensitivity and Gum Mint is stannous fluoride. There are 12 other brand versions of stannous fluoride.

What is the NDC code for SENSODYNE Sensitivity and Gum Mint 1.1 mg/g?

The NDC (National Drug Code) for SENSODYNE Sensitivity and Gum Mint 1.1 mg/g is 0135-5023, listed by Haleon US Holdings LLC.

Product NDC

0135-5023

Package NDC

0135-5023-01

Other Stannous Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)