TOMS OF MAINE WICKED FRESH SPEARMINT ICE

SODIUM MONOFLUOROPHOSPHATE DENTAL HUMAN OTC DRUG

TOMS OF MAINE WICKED FRESH SPEARMINT ICE is an FDA drug label for the active ingredient SODIUM MONOFLUOROPHOSPHATE manufactured by Tom's of Maine, Inc. 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 20260810.

Generic name
SODIUM MONOFLUOROPHOSPHATE
Manufacturer
Tom's of Maine, Inc.
Product type
HUMAN OTC DRUG
Route
DENTAL
Dosage form
N/A
NDC
51009-860
Application
M021
Label effective
20260810

About this product

TOMS OF MAINE WICKED FRESH SPEARMINT ICE is an FDA-registered drug product whose active ingredient is SODIUM MONOFLUOROPHOSPHATE. It is labelled by Tom's of Maine, Inc. taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 51009-860, application M021, label effective 20260810. It is one of 59 FDA drug label records sharing the active ingredient SODIUM MONOFLUOROPHOSPHATE. 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 SODIUM MONOFLUOROPHOSPHATE are most often described in connection with: helps protect, against cavities. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Indications & Usage

Use helps protect against cavities

Dosage & Administration

Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

Warnings

Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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How products containing SODIUM MONOFLUOROPHOSPHATE compare

FDA lists 59 drug label records with SODIUM MONOFLUOROPHOSPHATE 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 17
— — Tom's of Maine, Inc. 14
— — Universal Distribution Center LLC 4
— — White Glo USA Inc 4
— — Wessco International 3

Frequently asked questions

What is TOMS OF MAINE WICKED FRESH SPEARMINT ICE used for?
Use helps protect against cavities

Who makes TOMS OF MAINE WICKED FRESH SPEARMINT ICE?
Tom's of Maine, Inc. is the labeler of record for TOMS OF MAINE WICKED FRESH SPEARMINT ICE. 59 FDA label records share the active ingredient SODIUM MONOFLUOROPHOSPHATE, 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 TOMS OF MAINE WICKED FRESH SPEARMINT ICE 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 TOMS OF MAINE WICKED FRESH SPEARMINT ICE 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 SODIUM MONOFLUOROPHOSPHATE?
Yes. 59 FDA drug label records list SODIUM MONOFLUOROPHOSPHATE 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 TOMS OF MAINE WICKED FRESH SPEARMINT ICE 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.