Thera Plus Max Strength Lidocaine Pain Relief Liquid
Thera Plus Max Strength Lidocaine Pain Relief Liquid is an FDA drug label for the active ingredient LIDOCAINE HYDROCHLORIDE manufactured by Fourstar Group 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 20231130.
- Generic name
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Fourstar Group USA, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 80684-098
- Application
- M017
- Label effective
- 20231130
About this product
Thera Plus Max Strength Lidocaine Pain Relief Liquid is an FDA-registered drug product whose active ingredient is LIDOCAINE HYDROCHLORIDE. It is labelled by Fourstar Group USA, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 80684-098, application M017, label effective 20231130. It is one of 110 FDA drug label records sharing the active ingredient LIDOCAINE HYDROCHLORIDE. 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 HYDROCHLORIDE are most often described in connection with: temporarily relieves, minor pain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses temporarily relieves minor pain
Dosage & Administration
Directions adults and children over 12 years: • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. • children 12 years or younger. ask a doctor
Warnings
Warnings For external use only. Flammable • keep away from fire or flame Do not use • on large areas of the body or on cut, irritated or swollen skin • on puncture wounds • for more than one week without consulting a doctor When using this product • use only as directed. Read and follow all directions and warnings in this carton. • do not allow contact with the eyes and mucous membranes • do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use • do not use at the same time as other topical analgesics Stop use and ask a doctor if • condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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View labelHow products containing LIDOCAINE HYDROCHLORIDE compare
FDA lists 110 drug label records with LIDOCAINE HYDROCHLORIDE 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 |
|---|---|---|---|
| — | — | Medical Purchasing Solutions, LLC | 18 |
| — | — | Asclemed USA, Inc. | 6 |
| — | — | Water-Jel Technologies | 6 |
| — | — | SKINS SEXUAL HEALTH LIMITED | 5 |
| — | — | Nantong Health & Beyond Hygienic Products Inc. | 4 |
Frequently asked questions
What is Thera Plus Max Strength Lidocaine Pain Relief Liquid used for?
Uses temporarily relieves minor pain
Who makes Thera Plus Max Strength Lidocaine Pain Relief Liquid?
Fourstar Group USA, Inc. is the labeler of record for Thera Plus Max Strength Lidocaine Pain Relief Liquid. 110 FDA label records share the active ingredient LIDOCAINE HYDROCHLORIDE, 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 Thera Plus Max Strength Lidocaine Pain Relief Liquid 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 Thera Plus Max Strength Lidocaine Pain Relief Liquid 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 HYDROCHLORIDE?
Yes. 110 FDA drug label records list LIDOCAINE HYDROCHLORIDE 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 Thera Plus Max Strength Lidocaine Pain Relief Liquid 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.