LIDOCAINE by PHARMACURE LLC LIDOCAINE patch

LIDOCAINE by

Drug Labeling and Warnings

LIDOCAINE by is a Prescription medication manufactured, distributed, or labeled by PHARMACURE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

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

Do not use on the face or rashes, on wounds or damaged skin, in the eyes, mouth, or other mucous membranes, on genitals, with a heating pad, any patch from a pouch that has been opened for 7 or more days.

Ask a doctor before use if you are allergic to topical products, you are taking a diuretic, you have high blood pressure, heart disease, kidney disease, or you are pregnant.

When using this product wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and consult your physician if rash, irritation, or itching develops, or condition worsens.

If pregnant or breastfeeding, ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If product is put in mouth, get medical help of contact a Poison Control Center right away. Package is not child resistant. Dispose of the used patches by folding sticky ends together.

Directions

Adults and children 12 years and over: apply 1 to 2 patches to the affected area of intact skin. Lidocaine patch should be removed after 12 hours of continuous use and remain off for at least 12 hours.

SPL UNCLASSIFIED SECTION

INSTRUCTIONS FOR USE

• Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors 
• Safely discard the remaining unused pieces of cut patches where children and pets cannot reach 
• Remove the transparent protective film (clear plastic barrier) before application of patches to the skin 
• Apply immediately after removing the protective film Apply 1 patch to the affected area so that the patch covers all or most of the painful area
• Remove patch if irritation occurs

Children under 12 years of age: Consult a doctor.

Inactive ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, isopropyl myristate, polyacrylic acid, propyl p-hydroxybenzoate, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

Other information

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

Product label

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79643-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79643-005-01	10 in 1 BOX	11/29/2024
1		14 g in 1 PATCH; 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	11/29/2024

Labeler - PHARMACURE LLC (055983858)