Moon Whitening Gel Anticavity

SODIUM FLUORIDE TOPICAL HUMAN OTC DRUG

Moon Whitening Gel Anticavity is an FDA drug label for the active ingredient SODIUM FLUORIDE manufactured by Moon Oral Care, LLC administered by TOPICAL. 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 20231212.

Generic name
SODIUM FLUORIDE
Manufacturer
Moon Oral Care, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
82214-004
Application
M022
Label effective
20231212

About this product

Moon Whitening Gel Anticavity is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Moon Oral Care, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82214-004, application M022, label effective 20231212. It is one of 263 FDA drug label records sharing the active ingredient SODIUM 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 SODIUM FLUORIDE are most often described in connection with: children years, pea sized, supervised brushing, minimize swallowing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredient: Sodium Fluoride 0.24% (0.14% w/v active fluoride ion) Anticavity

Indications & Usage

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing.

Dosage & Administration

Directions: Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 years ask a dentist.

Warnings

Contains sodium fluoride. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

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How products containing SODIUM FLUORIDE compare

FDA lists 263 drug label records with SODIUM 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 34
— — The Procter & Gamble Manufacturing Company 25
— — Church & Dwight Co., Inc. 14
— — Burkhart Dental Supply Inc 12
— — Dharma Research, inc. 12

Frequently asked questions

What is Moon Whitening Gel Anticavity used for?
Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing.

Who makes Moon Whitening Gel Anticavity?
Moon Oral Care, LLC is the labeler of record for Moon Whitening Gel Anticavity. 263 FDA label records share the active ingredient SODIUM 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 Moon Whitening Gel Anticavity come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Moon Whitening Gel Anticavity 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 FLUORIDE?
Yes. 263 FDA drug label records list SODIUM 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 Moon Whitening Gel Anticavity 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.