Sonacaine Topical Anesthetic With Menthol

LIDOCAINE TOPICAL HUMAN OTC DRUG

Sonacaine Topical Anesthetic With Menthol is an FDA drug label for the active ingredient LIDOCAINE manufactured by Filltech USA, 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 20231109.

Generic name
LIDOCAINE
Manufacturer
Filltech USA, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
62221-935
Application
M017
Label effective
20231109

About this product

Sonacaine Topical Anesthetic With Menthol is an FDA-registered drug product whose active ingredient is LIDOCAINE. It is labelled by Filltech USA, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 62221-935, application M017, label effective 20231109. It is one of 152 FDA drug label records sharing the active ingredient LIDOCAINE. 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 LIDOCAINE are most often described in connection with: temporary relieves, itching due, minor cuts, burns insect, skin irritations. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Lidocaine 4%

Indications & Usage

Uses: temporary relieves pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Dosage & Administration

Directions: Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Warnings

Warnings: For external use only.

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How products containing LIDOCAINE compare

FDA lists 152 drug label records with LIDOCAINE 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
— — Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 10
— — Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 9
— — Proficient Rx LP 6
— — Bryant Ranch Prepack 5
— — Preferred Pharmaceuticals Inc. 5

Recall and safety notices

2 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-1242-2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144 Filltech USA, LLC Class II Terminated 20200422
D-1241-2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698 Filltech USA, LLC Class II Terminated 20200422

Frequently asked questions

What is Sonacaine Topical Anesthetic With Menthol used for?
Uses: temporary relieves pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Who makes Sonacaine Topical Anesthetic With Menthol?
Filltech USA, LLC is the labeler of record for Sonacaine Topical Anesthetic With Menthol. 152 FDA label records share the active ingredient LIDOCAINE, 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 Sonacaine Topical Anesthetic With Menthol 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 Sonacaine Topical Anesthetic With Menthol 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 LIDOCAINE?
Yes. 152 FDA drug label records list LIDOCAINE 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 Sonacaine Topical Anesthetic With Menthol been recalled?
2 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.