LIDOPRO PATCH- lidocaine, menthol, and methyl salicylate patch

LidoPro Patch by

Drug Labeling and Warnings

LidoPro Patch by is a Otc medication manufactured, distributed, or labeled by Terrain Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Methemoglobinemia

Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue lidocaine-containing products and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

Active Ingredient

Lidocaine 4%

Purpose

Topical Analgesic

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Active Ingredient

Methyl Salicylate 4%

Purpose

Topical Analgesic

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

For external use only

Stomach bleeding warning

This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you

are age 60 or older

have had stomach ulcers or bleeding problems

take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)

take a blood thinning (anticoagulant) or steroid drug

have three or more alcoholic drinks every day while using this product

take more or for a longer time than directed

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

if allergic to any NSAIDS

right before or after heart surgery

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

the stomach bleeding warning applies to you

you are taking a diuretic

you have high blood pressure, heart disease, or kidney disease

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

the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and consult your physician if

stomach pain or upset gets worse or lasts

rash, irritation, or itching develops

you feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)

condition worsens

If pregnant or breast feeding,

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

Keep out of reach of children.

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

Directions

Adults 18 years and older:

Apply patch to affected area 1 to 2 times daily or as directed.

Instructions for Use

clean and dry affected area

open pouch and remove one patch containing medical adhesive backing

remove protective film from both patch and medical adhesive

apply one patch to the affected area of pain and leave in place for 8 to 12 hours

if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours

only use one patch at a time

do not use more than 2 patches per day

wash hands with soap and water after applying or removing patch

reseal pouch containing unused patches after each use

Children under 18 years of age: Do not use

Other information

some individuals may not experience pain relief until several minutes or hours after applying the patch

avoid storing product in direct sunlight

protect product from excessive moisture

store at 67-77°F (19-25°C)

INACTIVE INGREDIENT

Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxynol-30, Polyacrylic Acid, Polysorbate 80, Sodium Polyacrylate, Sorbitan Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide, Water

QUESTIONS

Manufactured For:

Terrain Pharmaceuticals

Reno, NV 89501

Formulated and Designed in Nevada

Assembled in China

Patent Pending

LidoProTM patch

For questions or comments, call

877-985-8377

Principal Display Panel

NDC: 53225-1023-1

Professional Use Only

LidoPro ™ patch

Transdermal Pain Relief Patch & Medical Adhesive

Deep Penetrating
Long Lasting
Soothing
15 Patches

INGREDIENTS AND APPEARANCE

LIDOPRO PATCH 
lidocaine, menthol, and methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53225-1023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 100 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	4 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYL ACRYLATE (UNII: WC487PR91H)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ACRYLIC ACID (UNII: J94PBK7X8S)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53225-1023-1	15 in 1 BOX	12/02/2014
1		5 in 1 POUCH
1		8500 mg 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 not final	part348	12/02/2014

Labeler - Terrain Pharmaceuticals (078358750)