Sensodyne Complete Protection 1.1 mg/g

stannous fluoride · PASTE · Haleon US Holdings LLC

1 Recall on Record

Plain English

Sensodyne Complete Protection is a paste containing stannous fluoride at 1.1 mg/g, taken dental. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name: Sensodyne Complete Protection
Generic Name: stannous fluoride
NDC Code (Product): 0135-0573
Manufacturer: Haleon US Holdings LLC
Strength: 1.1 mg/g
Dosage Form: PASTE
Route: DENTAL
Marketing Status
Application #: M022
Marketing Start: 07/14/2014

Recall History

1 Recall on Record

Class II07/15/2015

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

oral discomfort17 reports

oral mucosal exfoliation8 reports

lip swelling7 reports

oral pain7 reports

stomatitis7 reports

dyspnoea6 reports

glossodynia6 reports

toothache6 reports

cough5 reports

drug ineffective5 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • aids in the prevention of dental cavities. • helps prevent gingivitis, an early form of gum disease. • 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 may be 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 Complete Protection used for?

Sensodyne Complete Protection contains stannous fluoride. It is a paste taken dental. Consult your doctor for specific uses.

Is Sensodyne Complete Protection a controlled substance?

Sensodyne Complete Protection is not classified as a controlled substance by the DEA.

What is the generic name for Sensodyne Complete Protection?

The generic name for Sensodyne Complete Protection is stannous fluoride. There are 11 other brand versions of stannous fluoride.

What is the NDC code for Sensodyne Complete Protection 1.1 mg/g?

The NDC (National Drug Code) for Sensodyne Complete Protection 1.1 mg/g is 0135-0573, listed by Haleon US Holdings LLC.

Product NDC

0135-0573

Package NDC

0135-0573-02

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)