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LidoPro Patch by Terrain Pharmaceuticals

Medically reviewed on Dec 29, 2017

Dosage form: patch
Ingredients: LIDOCAINE HYDROCHLORIDE 4mg in 100mg, MENTHOL 5mg in 100mg, METHYL SALICYLATE 4mg in 100mg
Labeler: Terrain Pharmaceuticals
NDC Code: 53225-1023

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

LidoPro Patch

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)

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

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

LIDOPRO PATCH 
lidocaine, menthol, and methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53225-1023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 100 mg
MENTHOL (MENTHOL) MENTHOL5 mg  in 100 mg
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE4 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
2-ETHYLHEXYL ACRYLATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
SODIUM POLYACRYLATE (8000 MW) 
NONOXYNOL-30 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
ACRYLIC ACID 
SORBITAN SESQUIOLEATE 
STARCH, CORN 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:53225-1023-115 POUCH in 1 BOX
15 PATCH in 1 POUCH
18500 mg in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/02/2014
Labeler - Terrain Pharmaceuticals (078358750)
Registrant - Wuhan Bingbing Pharmaceutical Co., Ltd. (529613802)

 
Terrain Pharmaceuticals

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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