LIDOCORE (SINGLE UNIT PATCH)- lidocaine 4% patch

LIDOCORE (single unit patch) by

Drug Labeling and Warnings

LIDOCORE (single unit patch) 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%

Purpose

Topical anesthetic

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
• With a heating pad
• 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 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.

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 the skin (see illustration). Apply 1 patch at a time to affected area, not more than 3 to 4 times daily. Remove patch from the skin after at most 8-hour application. Children under 12 years of age: Consult a doctor.

Other Information:

• Avoid storing product in direct sunlight.
• Protect product from excessive moisture.

INACTIVE INGREDIENT

Inactive Ingredients:Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaoloin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

QUESTIONS

​Questions or comments:833.711.8833

• info@ionpharmausa.com

PRINCIPAL DISPLAY PANEL

NDC: 82944-103-01

LIDOCORE
Lidocaine 4% Topical Anesthetic

TOPICAL PAIN PATCH
For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective
Long Lasting Relief

1 PATCH
5.5 x 3.94 (14cm x 10cm)

APPLY FOR 8 HOURS

ION PHARMA

INGREDIENTS AND APPEARANCE

LIDOCORE (SINGLE UNIT PATCH) 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82944-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
POVIDONE K90 (UNII: RDH86HJV5Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82944-103-01	1 in 1 POUCH; Type 0: Not a Combination Product	10/01/2023

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)