LIDOSYNC

LIDOSYNC is an FDA-registered drug product whose active ingredient is LIDOCAINE 4%, MENTHOL 1%. It is labelled by Ion Pharma, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82944-104, application 505G(a)(3), label effective 20260629. It is one of 3 FDA drug label records sharing the active ingredient LIDOCAINE 4%, MENTHOL 1%. 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.

Across FDA labelling, products containing LIDOCAINE 4%, MENTHOL 1% are most often described in connection with: lidocaine menthol, one patch, reach children, affected area, relief flexible, drug facts, active ingredients, purpose topical. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Drug Facts Active ingredients: Lidocaine 4% Menthol 1% Purpose Topical anesthetic - Topical analgesic INDICATIONS & USAGE Uses: For temporary relief of pain. Warnings For external use only DO NOT USE Do not use: More than one patch on your body at a time - On wounds or damaged skin - For more than one week without consulting a doctor - If you are allergic to any ingredients of this product. WHEN USING When using this product: Use only as directed - Avoid contact with the eyes, mucous membranes or rashes - Do not bandage tightly STOP USE Stop use and consult a doctor if: Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering - Conditions worsen - Symptoms persist for more than 7 ... PREGNANCY OR BREAST FEEDING If pregnant or breastfeeding: Ask a health professional before use. KEEP OUT OF REACH OF CHILDREN Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. DOSAGE & ADMINISTRATION Directions: Adults, or children over the age of 12: Clean and dry affected area. Remove film from patch and apply to skin (see illustration). Apply one patch at a time to affected area, not more ... Other Information: Store at 68 °F-77° F (20 °C-25° C.) Store in a clean, dry place without direct sunlight. Inactive Ingredients: Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrroliodone K90, Propylene ... QUESTIONS ​Questions or Comments: 833.711.8833 - [email protected] PRINCIPAL DISPLAY PANEL NDC 82944-104-10 - LIDOSYNC - Lidocaine 4% Menthol 1% TOPICAL PAIN PATCH - For Temporary Pain Relief - Flexible Patch Innovation - Soothing and Effective - Long Lasting Relief - 10 FLEXIBLE ... INGREDIENTS AND APPEARANCE Product Information

Directions Directions: Adults, or children over the age of 12: Clean and dry affected area. Remove film from patch and apply to skin (see illustration). Apply one patch at a time to affected area, not more than 3 to 4 time daily. Remove patch from the skin after at most 8-hour application. Children under 12 years of age: consult a doctor.

Warnings For external use only

FDA lists 3 drug label records with LIDOCAINE 4%, MENTHOL 1% 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.

What is LIDOSYNC used for?
Drug Facts Active ingredients: Lidocaine 4% Menthol 1% Purpose Topical anesthetic - Topical analgesic INDICATIONS & USAGE Uses: For temporary relief of pain. Warnings For external use only DO NOT USE Do not use: More than one patch on your body at a time - On wounds or damaged skin - For more than one week without consulting a doctor - If you are allergic to any ingredients of this product. WHEN …

Who makes LIDOSYNC?
Ion Pharma, LLC is the labeler of record for LIDOSYNC. 3 FDA label records share the active ingredient LIDOCAINE 4%, MENTHOL 1%, 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 LIDOSYNC 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 LIDOSYNC 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 4%, MENTHOL 1%?
Yes. 3 FDA drug label records list LIDOCAINE 4%, MENTHOL 1% 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 LIDOSYNC 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.