Terocin
Terocin is an FDA drug label for the active ingredient LIDOCAINE, MENTHOL manufactured by ASCLEMED USA INC. 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 20260505.
- Generic name
- LIDOCAINE, MENTHOL
- Manufacturer
- ASCLEMED USA INC.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 87063-195
- Application
- 505G(a)(3)
- Label effective
- 20260505
About this product
Terocin is an FDA-registered drug product whose active ingredient is LIDOCAINE, MENTHOL. It is labelled by ASCLEMED USA INC. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87063-195, application 505G(a)(3), label effective 20260505. It is one of 13 FDA drug label records sharing the active ingredient LIDOCAINE, MENTHOL. 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, MENTHOL are most often described in connection with: temporarily relief, minor aches, muscle pains, arthritis simple, backache strains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses: For the temporarily relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Dosage & Administration
Directions: Adults and childred 12 years and over: Apply patch to affected area 1 to 2 times daily or as directed. Instructions for use: Clean and dry the affected area Open pouch and remove one patch Remove any protective film and apply directly to affected area of pain Wash hands with soap and water after applying patch Reseal pouch containing unused patches after each use
Warnings
Warnings: Only for external use. Use only as directed or by a health professional. Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes. Do not cover with bandage. Consult your physician: if pregnant or pain persists or worsens. Keep out of reach of children. Consult physician for children under 12.
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View labelHow products containing LIDOCAINE, MENTHOL compare
FDA lists 13 drug label records with LIDOCAINE, MENTHOL 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 form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Kareway Product, Inc. | 2 |
| — | — | Proficient Rx LP | 2 |
| — | — | ARMY AND AIR FORCE EXCHANGE SERVICE | 1 |
| — | — | ASCLEMED USA INC. | 1 |
| — | — | Amerisource Bergen | 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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0713-2026 | Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01. | Asclemed USA Inc. | Class III | Ongoing | 20260729 |
| D-0658-2026 | Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01. | Asclemed USA Inc. | Class II | Ongoing | 20260708 |
| D-0659-2026 | Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01. | Asclemed USA Inc. | Class II | Ongoing | 20260708 |
| D-0555-2026 | Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc. | Asclemed USA Inc. | Class II | Ongoing | 20260610 |
| D-0330-2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608 | Asclemed USA Inc. dba Enovachem Pharmaceuticals | Class III | Ongoing | 20210421 |
Frequently asked questions
What is Terocin used for?
Uses: For the temporarily relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Who makes Terocin?
ASCLEMED USA INC. is the labeler of record for Terocin. 13 FDA label records share the active ingredient LIDOCAINE, MENTHOL, 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 Terocin 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 Terocin 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, MENTHOL?
Yes. 13 FDA drug label records list LIDOCAINE, MENTHOL 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 Terocin 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.