LIDOSYNC- lidocaine 4%, menthol 1% 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 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 - info@ionpharmausa.com
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

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 days
• Symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding:Ask a health professional before use.

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.

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.

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.

QUESTIONS

​Questions or Comments:833.711.8833

• info@ionpharmausa.com

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

INGREDIENTS AND APPEARANCE

LIDOSYNC 
lidocaine 4%, menthol 1% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82944-104
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

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
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)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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: 82944-104-10	10 in 1 BOX	10/01/2023
1		1 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	10/01/2023

Labeler - Ion Pharma, LLC (118739596)