Walgreens Restore and Defend

STANNOUS FLUORIDE DENTAL HUMAN OTC DRUG

Walgreens Restore and Defend is an FDA drug label for the active ingredient STANNOUS FLUORIDE manufactured by Walgreens administered by DENTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260602.

Generic name
STANNOUS FLUORIDE
Manufacturer
Walgreens
Product type
HUMAN OTC DRUG
Route
DENTAL
Dosage form
N/A
NDC
0363-1599
Application
M021
Label effective
20260602

About this product

Walgreens Restore and Defend is an FDA-registered drug product whose active ingredient is STANNOUS FLUORIDE. It is labelled by Walgreens taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 0363-1599, application M021, label effective 20260602. It is one of 19 FDA drug label records sharing the active ingredient STANNOUS FLUORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing STANNOUS FLUORIDE are most often described in connection with: years age, older apply, least inch, produc tonto, soft bristle, toothbrush brush, teeth thoroughly, one minute. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion) .... Anticavity/Antihypersensitivity

Indications & Usage

Adults and children 12 years of age and older: apply at least a 1-inch strip of the produc tonto a soft bristle toothbrush. brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. do not swallow. children under 12 years of age: consult a dentist or doctor.

Dosage & Administration

Aids in the prevention of dental cavities. Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Warnings

When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth pay indicate a serious problem that may need prompt care by a dentist. Pain/sensitivity still persists after 4 weeks of use.

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How products containing STANNOUS FLUORIDE compare

FDA lists 19 drug label records with STANNOUS FLUORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Colgate-Palmolive Company 4
— — Dharma Research, Inc. 4
— — Burkhart Dental Supply Inc 2
— — COLGATE PALMOLIVE COMPANY 2
— — Church & Dwight Co., Inc. 1

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0530-2016 Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
D-0557-2016 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
D-0535-2016 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
D-0537-2016 Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106
D-0549-2016 Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Walgreens Infusion Services Class II Terminated 20160106

Frequently asked questions

What is Walgreens Restore and Defend used for?
Adults and children 12 years of age and older: apply at least a 1-inch strip of the produc tonto a soft bristle toothbrush. brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. do not swallow. children under 12 years of age: consult …

Who makes Walgreens Restore and Defend?
Walgreens is the labeler of record for Walgreens Restore and Defend. 19 FDA label records share the active ingredient STANNOUS FLUORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Walgreens Restore and Defend come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Walgreens Restore and Defend prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing STANNOUS FLUORIDE?
Yes. 19 FDA drug label records list STANNOUS FLUORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Walgreens Restore and Defend been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.