MAXIMUM STRENGTH 4% LIDOCAINE PATCH- lidocaine patch

Maximum Strength 4% Lidocaine Patch by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

for temporary relief of pain

Warnings

For external use only

Do Not Use

• more than one 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 This Product

• use only as directed rashes
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly

Stop Use and Ask a Doctor if

• localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling or blistering
• conditions worsen
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

If Pregnant or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children and Pets

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 affected area
• remove backing layer from patch and apply to the affected area (see pictorial representation)
• remove patch from the skin after at most 8-hour application
• apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Other information

• store at 20-25°C (68-77°F)
• protect product from direct sunlight and excessive moisture
  

Inactive Ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, polyvinylpyrrolidone K90, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Questions and Comments

Call 1-855-314-1850

Bulk Package Label

MAXIMUM STRENGTH
Pansolix® Pain Relieving Patch
4% Lidocaine
ODORFREE
NUMBS SENSITIVE NERVES FOR TEMPORARY RELIEF OF PAIN

• BACK NECK
• KNEES
• ELBOWS
• SHOULDERS

30 PATCHES 3-15/16" x 5-1/2" (10 cm x 14 cm)

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH 4% LIDOCAINE PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85185-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K90 (UNII: RDH86HJV5Z)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
KAOLIN (UNII: 24H4NWX5CO)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85185-001-30	30 in 1 BOX	03/01/2025
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	03/01/2025

Labeler - Solis Pharmaceuticals Inc. (119380963)

Registrant - Solis Pharmaceuticals Inc. (119380963)