Crest Pro-Health Gum DetoxifyWinter Mint

CETYLPYRIDINIUM CHLORIDE ORAL HUMAN OTC DRUG

Crest Pro-Health Gum DetoxifyWinter Mint is an FDA drug label for the active ingredient CETYLPYRIDINIUM CHLORIDE manufactured by The Procter & Gamble Manufacturing Company administered by ORAL. 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 20260414.

Generic name
CETYLPYRIDINIUM CHLORIDE
Manufacturer
The Procter & Gamble Manufacturing Company
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
84126-648
Application
M022
Label effective
20260414

About this product

Crest Pro-Health Gum DetoxifyWinter Mint is an FDA-registered drug product whose active ingredient is CETYLPYRIDINIUM CHLORIDE. It is labelled by The Procter & Gamble Manufacturing Company taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 84126-648, application M022, label effective 20260414. It is one of 14 FDA drug label records sharing the active ingredient CETYLPYRIDINIUM CHLORIDE. 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 CETYLPYRIDINIUM CHLORIDE are most often described in connection with: helps prevent, reduce plaque, development gingivitis, bleeding gums. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Cetylpyridinium chloride 0.07%

Indications & Usage

Uses helps prevent and reduce plaque and gingivitis helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Dosage & Administration

Directions use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use adults and children 6 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use

Warnings

Warnings Ask a dentist if symptoms persist or condition worsens after regular use. Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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CETYLPYRIDINIUM CHLORIDE

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How products containing CETYLPYRIDINIUM CHLORIDE compare

FDA lists 14 drug label records with CETYLPYRIDINIUM CHLORIDE 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
— — The Procter & Gamble Manufacturing Company 3
— — Colgate-Palmolive Company 2
— — Nice-Pak Products, LLC 2
— — Sage Products LLC 2
— — Gervest USA Inc 1

Frequently asked questions

What is Crest Pro-Health Gum DetoxifyWinter Mint used for?
Uses helps prevent and reduce plaque and gingivitis helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Who makes Crest Pro-Health Gum DetoxifyWinter Mint?
The Procter & Gamble Manufacturing Company is the labeler of record for Crest Pro-Health Gum DetoxifyWinter Mint. 14 FDA label records share the active ingredient CETYLPYRIDINIUM CHLORIDE, 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 Crest Pro-Health Gum DetoxifyWinter Mint come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Crest Pro-Health Gum DetoxifyWinter Mint 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 CETYLPYRIDINIUM CHLORIDE?
Yes. 14 FDA drug label records list CETYLPYRIDINIUM CHLORIDE 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 Crest Pro-Health Gum DetoxifyWinter Mint 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.