LIDOCAINE 4% PATCH- lidocaine 4% patch

Lidocaine 4% Patch by

Drug Labeling and Warnings

Lidocaine 4% Patch by is a Otc medication manufactured, distributed, or labeled by SOLA Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine

Purpose

Topical Anesthetic

Uses

For the temporary relief of pain

Warnings

For external use only

DO NOT USE

Do not use

• more than 1 patch 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 ask 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 breast-feeding, ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

• Clean and dry the affected area
• Open pouch and remove one patch
• Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
• Reseal pouch containing unused patches after each use
• 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

Other Ingredients

Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

PRINCIPAL DISPLAY PANEL

Questions or comments? 866-747-7365

Lidocaine 4% Patch

NDC: 70512-812-30

Qty: 30 patches

Manufactured for:

SOLA Pharmaceuticals

Baton Rouge, LA 70810

Made in China

INGREDIENTS AND APPEARANCE

LIDOCAINE 4% PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70512-812
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE K90 (UNII: RDH86HJV5Z)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
TARTARIC ACID (UNII: W4888I119H)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70512-812-30	30 in 1 BOX	10/12/2023
1		1 g 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	505G(a)(3)	10/12/2023

Labeler - SOLA Pharmaceuticals (080121345)