Lidopro Patch

Lidopro Patch
SPL v5
SPL
SPL Set ID 2791c44a-61de-45c8-9af7-50396bed0929
Route
TOPICAL
Published
Effective Date 2023-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 mg) Salicylic Acid (5 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-01-25 Until 2026-08-31

Description

Lidocaine 4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine 4%

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

Section 51727-6

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

Section 51945-4

Section 53413-1

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

Warnings

For external use only

Directions

Ad ults 18 years and older:

• Apply patch to affected area 1 to 2 times daily or as 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

If Pregnant Or

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.

Active Ingredient

Lidocaine 4%

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)

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

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.

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

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

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.

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


Structured Label Content

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Purpose

Topical Analgesic

Warnings

For external use only

Directions

Ad ults 18 years and older:

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

Do Not Use (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

If Pregnant Or (If pregnant or)

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.

Active Ingredient

Lidocaine 4%

Other Information (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)

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

When Using This Product (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.

Stomach Bleeding Warning (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

Ask A Doctor Before Use If (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

Keep Out of Reach of Children. (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.

Stop Use and Consult Your Physician If (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


Advanced Ingredient Data


Raw Label Data

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