FDA Label for Lidosync
View Indications, Usage & Precautions
Lidosync Product Label
The following document was submitted to the FDA by the labeler of this product Ion Pharma, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(In Each Patch)
Lidocaine 4%
Menthol 1%
Methyl salicylate 2%
Purpose
Topical anesthetic
Topical analgesic
Topical analgesic
Indications & Usage
Uses: Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:
- muscle soreness
- strains
- sprains
- arthritis
- simple backache
- muscle stiffness
- bruises
Warnings
For external use only
Other
Stomach bleeding warning: This product contains a NSAID, which may cause stomach bleeding. The chance is small.but higher if you
- are aged 60 or older
- have had stomach ulcers or bleeding problems
- take other drugs containing an NSAID (Aspirin,Ibuprofen, Naproxen, or others)
- take a blood thinning (anticoagulant) or steroidal drug
- have three or more alcoholic drinks every day while using this product
- take more or for a longer time than directed.
Otc - Do Not Use
Do not use
- More than one patch on your body at a time
- On cut, irritated or swollen skin
- On puncture wounds
- If you are allergic to any active or inactive ingredients
- If pouch is damaged or opened.
Otc - When Using
When using this product
- Use only as directed
- Read and follow all directions and warnings
- Do not allow to contact with the eyes
- Do not use at the same time as other topical analgesics
- Do not bandage tightly or apply local heat(such as heating pads)to the area of use
- Do not microwave
- Dispose of used patch in manner that always keeps product away from children and pets.Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Otc - Stop Use
Stop use and consult 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
- You experience signs of skin injury, such as pain, swelling or blistering where the product was applied
- Stomach pain or upset gets worse or lasts
- You feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding).
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.
Directions
Adults, or children over the age of 12:Clean and dry affected area.
Apply sticky side of patch to affected area and leave in place for 8 hours.If pain lasts after using the first patch, a second patch may be applied. Only use one patch at a time. do not use more than 2 patches per day. Wash hands with soap and water after applying or removing patch. Reseal pouch containing unused patches immediately after each use. Children under 12 years of age: Do not use.
Other Information
- Store at 68°F-77°F (20 °C-25°C).
- Store in a clean, dry place without direct sunlight. Protect from excessive moisture.
- Some individuals may not experience pain relief until several minutes or hours after applying the patch.
Inactive Ingredients
Arnica Montana Flower Extract, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-tartaric Acid, Mineral Oil, Polyacrylic Acid, Propylene Glycol, Polysorbate 80, PVP, Sodium Polyacrylate, Titanium Dioxide, Water.
Principal Display Panel
NDC 82944-102-10
LIDOSYNC
Lidocaine 4%, Menthol 1%, Methyl Salicylate 2%
TOPICAL PAIN PATCH
For Temporary Pain Relief
Flexible Patch Innovation
Soothing and Effective
Long Lasting Relief
Qty: 10 Flexible Patches
(5 per Resealable Pouch) x2
3.94 x 5.5 (10cm x 14cm)
ION PHARMA
* Please review the disclaimer below.