LIDOSYNC- lidocaine 4%, menthol 1%, methyl salicylate 2% patch

LIDOSYNC by

Drug Labeling and Warnings

LIDOSYNC by is a Otc medication manufactured, distributed, or labeled by Ion Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

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

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.

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

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.

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.

QUESTIONS

​Questions or Comments:833.711.8833

• info@ionpharmausa.com

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

INGREDIENTS AND APPEARANCE

LIDOSYNC 
lidocaine 4%, menthol 1%, methyl salicylate 2% patch

Product 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 Drug	M017	06/01/2023

Labeler - Ion Pharma, LLC (118739596)