Lidocaine 4 Percent
Lidocaine 4 Percent is an FDA drug label for the active ingredient LIDOCAINE manufactured by Preferred Pharmaceuticals 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 20260609.
- Generic name
- LIDOCAINE
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 68788-4123
- Application
- 505G(a)(3)
- Label effective
- 20260609
About this product
Lidocaine 4 Percent is an FDA-registered drug product whose active ingredient is LIDOCAINE. It is labelled by Preferred Pharmaceuticals Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 68788-4123, application 505G(a)(3), label effective 20260609. 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: temporarily relieves, itching associated, minor burns, cuts scrapes, insect bites, skin irritations. 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 pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations
Dosage & Administration
Directions Adults and children 12 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. - Clean and dry the affected area. - Open pouch and remove one patch. - Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. - Wash hands with soap and water after handling the patches. - Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. - Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Children under 12 years: Ask a physician
Warnings
Warnings For external use only. Read all warnings and directions before use. Do not use • More than one patch at a time • On wounds or damaged skin • With a heating pad • If you are allergic to any ingredients of this product Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use. When using this product • Use only as directed. • Avoid contact with eyes , mucous membranes, or rashes • Do not tightly wrap or bandage the treated area Stop use and ask a physician: • If pregnant or breast feeding • If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center immediately.
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View labelHow 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 form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | 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 |
Frequently asked questions
What is Lidocaine 4 Percent used for?
Uses Temporarily relieves pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations
Who makes Lidocaine 4 Percent?
Preferred Pharmaceuticals Inc. is the labeler of record for Lidocaine 4 Percent. 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 Lidocaine 4 Percent 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 Lidocaine 4 Percent 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 Lidocaine 4 Percent 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.