LIDOPRO OINTMENT

Manufacturer
Lake Erie Medical DBA Quality Care Products LLC
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:16:52

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-523-012021-04-16C16284748780-1ba0f9c33-43e6-a910-e053-dadaa90a0b85LIDOPRO OINTMENT
55700-523-012021-01-29C16284748780-1ba0f9c33-43e6-a910-e053-dadaa90a0b85LIDOPRO OINTMENT

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-523-01GM - Gram55700-523f5cff2ea-88f7-4bfa-856d-86f5d3b1ab3512017-06-15
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
55700-52355700-523-01
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
8f12e70f-d2a7-4012-b3b6-d4100bb4eeb07d3113a3-aa2f-496b-b7cf-182aa7420ce02023-12-21WarningsExact identifier
spl id: 8f12e70f-d2a7-4012-b3b6-d4100bb4eeb0
spl set id: 7d3113a3-aa2f-496b-b7cf-182aa7420ce0

Reported adverse events (FAERS/openFDA)#

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