Label: LIDOSYNC- lidocaine 4%, menthol 1%, methyl salicylate 2% patch
- NDC Code(s): 82944-102-10
- Packager: Ion Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 24, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient(in each patch)
- Purpose
- INDICATIONS & USAGE
- Warnings
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SPL UNCLASSIFIED SECTION
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.
- DO NOT USE
-
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.
-
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).
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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
- Inactive Ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LIDOSYNC
lidocaine 4%, menthol 1%, methyl salicylate 2% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82944-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 2 g Inactive Ingredients Ingredient Name Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) KAOLIN (UNII: 24H4NWX5CO) TARTARIC ACID (UNII: W4888I119H) MINERAL OIL (UNII: T5L8T28FGP) POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82944-102-10 10 in 1 BOX 06/01/2023 1 5 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2023 Labeler - Ion Pharma, LLC (118739596)