LidoPro 4% Ointment

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2025-07-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:09:10

Label at a glance#

ProductLidoPro
Active ingredientCAPSAICIN, LIDOCAINE HYDROCHLORIDE, MENTHOL, UNSPECIFIED FORM, 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

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

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

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53225-1020-1

Preferred Pharmaceuticals Inc. NDC 68788-8314-1

LidoPro Topical Pain Relief Oint Applicator
LidoPro Topical Pain Relief Oint Applicator

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentPSN3
1601097LidoPro 0.0325 % / 4 % / 10 % / 27.5 % Topical OintmentPSN3
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]SBD3
1601095capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical OintmentSCD3
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentSY3
1601097LidoPro (capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % ) Topical OintmentSY3

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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8314-1LidoPro92 g in 1 BOTTLEOINTMENT923

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8314-1GM - Gram68788-83146a328cc4-317a-4110-898a-52e93277030712023-04-07
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 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-831468788-8314-1
53225-1020

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
LidoProCAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd2025-07-17WarningsExact identifier
ndc (package): 68788-8314-1
ndc (product): 68788-8314
ndc11 (package): 68788831401
spl id: f0f7b609-28f8-4f7a-8a34-63f82aedc5c0
spl set id: 3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd

Reported adverse events (FAERS/openFDA)#

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