FDA.reportPublic FDA data

LIDOPRO OINTMENT

Manufacturer
Aidarex Pharmaceuticals LLC
Effective date
2017-02-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:52

Label at a glance#

ProductLidoPro
Active ingredientCAPSAICIN, LIDOCAINE HYDROCHLORIDE, MENTHOL, METHYL SALICYLATE
Label structure13 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#

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

Manufactured for
Terrain Pharmaceuticals
Reno, NV 89501

Made in the U.S.A.
Patent Pending

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPL Label
SPL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentPSN1
1601097LidoPro 0.0325 % / 4 % / 10 % / 27.5 % Topical OintmentPSN1
1601097capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical Ointment [LidoPro]SBD1
1601095capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical OintmentSCD1
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentSY1
1601097LidoPro (capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % ) Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-153-012020-01-31C16284748780-19d75b9d0-81ee-f424-e053-dadaa90a57ceLIDOPRO OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-153-01LidoPro121 g in 1 BOTTLEOINTMENT1211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-153LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20170222_7f672876-477c-4333-a7de-53f312190661.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-153-01GM - Gram53217-15357acd430-641a-4a4a-8889-8e5ec8e2fcd012017-03-06
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
53217-15353217-153-01
53225-1022

Ingredients#

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

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

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

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
140ccf92-6551-4966-b536-7505926acd2a7f672876-477c-4333-a7de-53f3121906612017-02-21WarningsExact identifier
spl id: 140ccf92-6551-4966-b536-7505926acd2a
spl set id: 7f672876-477c-4333-a7de-53f312190661

Reported adverse events (FAERS/openFDA)#

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