FDA.reportPublic FDA data

TP05-LidoPro 4% Ointment

Manufacturer
Medsource Pharmaceuticals | Westwood Laboratories, LLC
Effective date
2024-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:10:17

Label at a glance#

ProductLidoPro
Active ingredientCAPSAICIN, LIDOCAINE HYDROCHLORIDE, MENTHOL, METHYL SALICYLATE
Label structure15 sections

Indications and uses

For the temporary relief of joint pain and muscle pain associated with: Arthritis Simple Backache Muscle Sprains Muscle Strains

Dosage and administration

Ad ults and Children 12 Years of Age and Older: Clean and dry the affected area Apply product directly to your skin, up to 4 times daily affected area Wash hands immediately after use Children Under 12 Years of Age : Consult physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.0325%

Purpose

OTC - PURPOSE SECTION

Counterirritant

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

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

Counterirritant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of joint pain and muscle pain associated with:

  • Arthritis
  • Simple Backache
  • Muscle Sprains
  • Muscle Strains

Warnings

WARNINGS SECTION

For External Use Only

Do Not Use

OTC - DO NOT USE SECTION

  • On damaged, irritated, or infected skin
  • With a bandage or heating pad
  • If you are allergic to any ingredients in this product

When Using This Product:

OTC - WHEN USING SECTION

Avoid contact with eyes and mucus membranes

Stop Use and Ask a Doctor If:

OTC - ASK DOCTOR SECTION

  • Conditions worsens
  • Excessive skin irritation develops
  • Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

If Pregnant orBreast-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 ingested seek medical help or contact a Poison Control Center immediately

Flammable:

STORAGE AND HANDLING SECTION

Keep away from excessive heat or open flame

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 Years of Age and Older:

  • Clean and dry the affected area
  • Apply product directly to your skin, up to 4 times daily affected area
  • Wash hands immediately after use

Children Under 12 Years of Age:Consult physician

Other Information

SPL UNCLASSIFIED SECTION

  • Store in a cool, dry place with lid tightly closed
  • If the tamper-evident foil seal is not intact, do not use

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.

Questions or Comments?

OTC - QUESTIONS SECTION

info@terrainrx.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

232232

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-232LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [MEDSOURCE PHARMACEUTICALS]1Unmatched20240306_12daded2-c5f6-97cc-e063-6294a90aa6ee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53225-1020-1GM - Gram53225-102090722ca5-1b77-4826-84a4-3015f50099aa12022-11-07

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45865-23245865-232-01
53225-1020

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
INULINJOS53KRJ01IACT
STEARIC ACID4ELV7Z65APIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPSAICINS07O44R1ZMACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
52479ccc-6a68-ec3b-e063-6294a90a15b612daded2-c5f6-97cc-e063-6294a90aa6ee2026-05-20WarningsExact identifier
spl set id: 12daded2-c5f6-97cc-e063-6294a90aa6ee

Reported adverse events (FAERS/openFDA)#

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