FDA.reportPublic FDA data

LidoPro Pain Relief

Manufacturer
Clinic Pharma
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:37:59

Label at a glance#

ProductLidoPro Pain Relief
Active ingredientMENTHOL, (+)-, LIDOCAINE HYDROCHLORIDE, METHYL SALICYLATE, CAPSAICIN
Label structure9 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 skin, up to 4 times daily wash hands immediately after use Children under 12 years of age: Consult physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

  • Capsicum annum fruit extract (capsaicin)
  • Lidocaine HCL
  • Menthol
  • Methyl Salicylate

Purpose

OTC - PURPOSE SECTION

  • counterirritant
  • anesthetic
  • analgesic

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 the eyes and mucous membranes

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens
  • excessive skin
  • irritation develops
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within 3 days

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 ingested, seek medical help or contact a Poison Control Center immediately.

Flammable

OTHER SAFETY INFORMATION

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 skin, up to 4 times daily
  • wash hands immediately after use

Children under 12 years of age: Consult physician.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredient

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?

OTC - QUESTIONS SECTION

(800) 224-2048 or info@clinicpharma.com

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Entire LabelEntire Label

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
83881-001-35LidoPro Pain Relief1 in 1 BOXOINTMENT11
83881-001-35LidoPro Pain Relief9900 mg in 1 TUBE, WITH APPLICATOROINTMENT99001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83881-001LIDOPRO PAIN RELIEF (CAPSAICIN AND LIDOCAINE) OINTMENT [CLINIC PHARMA]1Current NDC, 2 package rows20241121_274611ea-7fc2-ba3f-e063-6294a90aa50f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83881-001-35GM - Gram83881-001e57a98cf-db46-483d-b965-2dec11cc439612025-01-14

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
83881-00183881-001-35

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
ALOE BARBADENSIS LEAF JUICEZY81Z83H0XIACT
TRIETHANOLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOL, (+)-C6B1OE8P3WACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
GLYCERYL STEARATE230OU9XXE4IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
METHYL SALICYLATELAV5U5022YACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
CAPSAICINS07O44R1ZMACTIB
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PEG-100 STEARATEYD01N1999RIACT
ALLANTOIN344S277G0ZIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
INULIN LAURYL CARBAMATE48RFF58ESGIACT
STEARIC ACID4ELV7Z65APIACT

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
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEClinic Pharma274611ea-7fc2-ba3f-e063-6294a90aa50f2024-11-19WarningsExact identifier
ndc (package): 83881-001-35
ndc (product): 83881-001
ndc11 (package): 83881000135
spl id: 274611ea-7fc3-ba3f-e063-6294a90aa50f
spl set id: 274611ea-7fc2-ba3f-e063-6294a90aa50f

Reported adverse events (FAERS/openFDA)#

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