LidoPro

Manufacturer
Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2023-10-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:24:12

Label at a glance#

ProductLidoPro
Active ingredientCAPSAICIN, LIDOCAINE HYDROCHLORIDE, MENTHOL, METHYL SALICYLATE
Label structure14 sections

Indications and uses

Temporarily relieves minor aches and muscles pains associated with: arthritis simple back pain strains muscle soreness

Dosage and administration

Ad ults 18 years and children 12 years and older: apply product directly to affected area product may be used as necessary, but should not be used more than four times per day. wash hands immediately afterwards Children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

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

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.0325%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 27.5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and muscles pains associated with:

  • arthritis
  • simple back pain
  • strains
  • muscle soreness

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on open wounds, cuts, damaged or infected skin
  • with bandage or a heating pad
  • if condition worsens or symptoms persists for more than 7 days
  • excessive skin irritation occurs

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you are allergic to any ingredients, PABA, aspirin products or sulfa

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

Store

STORAGE AND HANDLING SECTION

at 20○C - 25○C (68○F - 77○F)

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 years and children 12 years and older:

  • apply product directly to affected area
  • product may be used as necessary, but should not be used more than four times per day.
  • wash hands immediately afterwards

Children 12 years or younger: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

For Questions or Comments

OTC - QUESTIONS SECTION

Please Email info@TerrainRX.com

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

Made in the U.S.A.
Patent Pending

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LidoproLidopro

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-038LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [ASCLEMED USA, INC.]3Legacy NDC20231016_e48aa0ab-6aed-4dae-8e1c-dfae2e70f303.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-038-12GM - Gram76420-038032f6299-ed95-422e-8ccb-14115f71296b12022-10-06
76420-038-92GM - Gram76420-0386b730a32-df13-46f8-94ae-34f4e09bc9f012023-03-13
53225-1022-1GM - Gram53225-1022664bc9f1-64a7-464d-8bda-61847ab1119612015-01-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-03876420-038-12
53225-1022

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
35c72fa3-affe-f02e-e063-6394a90a7973e48aa0ab-6aed-4dae-8e1c-dfae2e70f3032025-05-23WarningsExact identifier
spl set id: e48aa0ab-6aed-4dae-8e1c-dfae2e70f303

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.