SENSODYNE Repair and Protect 1.1 mg/g

stannous fluoride · PASTE · Haleon US Holdings LLC

No Recall History

Plain English

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

Key Facts

Brand Name: SENSODYNE Repair and Protect
Generic Name: stannous fluoride
NDC Code (Product): 0135-0548
Manufacturer: Haleon US Holdings LLC
Strength: 1.1 mg/g
Dosage Form: PASTE
Route: ORAL
Marketing Status
Application #: M022
Marketing Start: 06/28/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective47 reports

oral discomfort47 reports

oral pain25 reports

toothache24 reports

lip swelling20 reports

stomatitis20 reports

condition aggravated17 reports

gingival pain17 reports

hyperaesthesia teeth16 reports

product use in unapproved indication15 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses aids in the prevention of dental cavities. 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. 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 Repair and Protect used for?

SENSODYNE Repair and Protect contains stannous fluoride. It is a paste taken oral. Consult your doctor for specific uses.

Is SENSODYNE Repair and Protect a controlled substance?

SENSODYNE Repair and Protect is not classified as a controlled substance by the DEA.

What is the generic name for SENSODYNE Repair and Protect?

The generic name for SENSODYNE Repair and Protect is stannous fluoride. There are 11 other brand versions of stannous fluoride.

What is the NDC code for SENSODYNE Repair and Protect 1.1 mg/g?

The NDC (National Drug Code) for SENSODYNE Repair and Protect 1.1 mg/g is 0135-0548, listed by Haleon US Holdings LLC.

Product NDC

0135-0548

Package NDC

0135-0548-01

Other Stannous Brands

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

Data from openFDA · Public domain (CC0 1.0)