Active Ingredients:
Lidocaine 4%
Menthol 1%
Lidosync Patch
FDA Label NDC 82944-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ion Pharma, Llc for the product Lidosync (NDC 82944-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Topical analgesic
Indications & Usage
Uses: For temporary relief of pain.
Warnings
- For external use only
Otc - 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.
Otc - When Using
When using this product:
- Use only as directed
- Avoid contact with the eyes, mucous membranes or rashes
- Do not bandage tightly
Otc - 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 days
- Symptoms clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding: Ask a health professional before use.
Otc - 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 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.
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 Glycol, Sodium Polyacrylate, Titanium Dioxide, Water.
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 PATCHES
3.94 x 5.5 (10cm x 14cm)
ION PHARMA
* Please review the disclaimer below.
