Colgate Total Sensitivity Mineral Shield

STANNOUS FLUORIDE DENTAL HUMAN OTC DRUG

Colgate Total Sensitivity Mineral Shield is an FDA drug label for the active ingredient STANNOUS FLUORIDE manufactured by Colgate-Palmolive Company 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 20260610.

Generic name
STANNOUS FLUORIDE
Manufacturer
Colgate-Palmolive Company
Product type
HUMAN OTC DRUG
Route
DENTAL
Dosage form
N/A
NDC
35000-283
Application
M021
Label effective
20260610

About this product

Colgate Total Sensitivity Mineral Shield is an FDA-registered drug product whose active ingredient is STANNOUS FLUORIDE. It is labelled by Colgate-Palmolive Company taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 35000-283, application M021, label effective 20260610. 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: prevention cavities, helps interfere, harmful effects, plaque associated, gingivitis builds, increasing protection, against painful, teeth cold. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Indications & Usage

Uses aids in the prevention of cavities 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 helps prevent gingivitis

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 bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth. do not swallow. children under 12 years of age: consult a dentist.

Warnings

Warnings When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist. Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. 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. Stop use and ask a dentist if 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 of periodontitis, a serious form of gum disease.

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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

Frequently asked questions

What is Colgate Total Sensitivity Mineral Shield used for?
Uses aids in the prevention of cavities 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 helps prevent gingivitis

Who makes Colgate Total Sensitivity Mineral Shield?
Colgate-Palmolive Company is the labeler of record for Colgate Total Sensitivity Mineral Shield. 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 Colgate Total Sensitivity Mineral Shield 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 Colgate Total Sensitivity Mineral Shield 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 Colgate Total Sensitivity Mineral Shield been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.