Perox-A-Mint Solution

HYDROGEN PEROXIDE BUCCAL HUMAN OTC DRUG

Perox-A-Mint Solution is an FDA drug label for the active ingredient HYDROGEN PEROXIDE manufactured by Sage Products, LLC administered by BUCCAL. 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 20260624.

Generic name
HYDROGEN PEROXIDE
Manufacturer
Sage Products, LLC
Product type
HUMAN OTC DRUG
Route
BUCCAL
Dosage form
N/A
NDC
53462-075
Application
M022
Label effective
20260624

About this product

Perox-A-Mint Solution is an FDA-registered drug product whose active ingredient is HYDROGEN PEROXIDE. It is labelled by Sage Products, LLC taken by buccal and marketed as a human otc drug product. Identifiers on file: NDC 53462-075, application M022, label effective 20260624. It is one of 28 FDA drug label records sharing the active ingredient HYDROGEN PEROXIDE. 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 HYDROGEN PEROXIDE are most often described in connection with: removal secretions, sore mouth. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Hydrogen Peroxide 1.5%

Indications & Usage

Use Aids in the removal of secretions associated with sore mouth

Dosage & Administration

Directions Use up to 4 times daily or as directed by a dentist or doctor. Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate. Children under 12 years of age: supervise use. Children under 3 years of age: consult a dentist or doctor.

Warnings

Warnings Do not use: For more than 7 days unless told to do so by a doctor. Avoid swallowing. Stop use and ask a doctor if: Sore mouth symptoms do not improve in 7 days. Swelling, rash or fever develops. Irritation, pain or redness persists of worsens. Keep out of reach of children. If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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How products containing HYDROGEN PEROXIDE compare

FDA lists 28 drug label records with HYDROGEN PEROXIDE 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
— — Medical Chemical Corporation 2
— — P & L Development, LLC 2
— — Strategic Sourcing Services LLC 2
— — 4 Visions LLC 1
— — Aero Healthcare US LLC 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-0837-2026 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26 Sage Products, LLC Class II Ongoing 20260909
D-0404-2018 Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6924 UPC 6 18029 83033 3 Sage Products Inc Class II Terminated 20180221
D-0353-2018 Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16 Sage Products Inc Class II Terminated 20180221
D-0360-2018 Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product code 6000, UPC 6 18029 8001 5 Sage Products Inc Class II Terminated 20180221
D-0348-2018 Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution. Manufactured by: Sage Products, LLC., 3909 Three Oaks Road, Cary, IL 60013 Product Code: 6434; UPC 6 18029 83035 7 Sage Products Inc Class II Terminated 20180221

Frequently asked questions

What is Perox-A-Mint Solution used for?
Use Aids in the removal of secretions associated with sore mouth

Who makes Perox-A-Mint Solution?
Sage Products, LLC is the labeler of record for Perox-A-Mint Solution. 28 FDA label records share the active ingredient HYDROGEN PEROXIDE, 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 Perox-A-Mint Solution come in?
administered by buccal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Perox-A-Mint Solution 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 HYDROGEN PEROXIDE?
Yes. 28 FDA drug label records list HYDROGEN PEROXIDE 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 Perox-A-Mint Solution 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.