LIDOPRO OINTMENT

Manufacturer
DirectRX
Effective date
2019-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:25:11

Label at a glance#

ProductLIDOPRO
Active ingredientLIDOCAINE HYDROCHLORIDE, CAPSAICIN, MENTHOL, METHYL SALICYLATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Capsaicin 0.0325%

OTC - PURPOSE SECTION


Lidocaine HCL 4%

OTC - ACTIVE INGREDIENT SECTION


Lidocaine HCL 4%

OTC - ACTIVE INGREDIENT SECTION


Menthol 10%

OTC - ACTIVE INGREDIENT SECTION


Methyl Salicylate 27.5%

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and muscles pains associated with:

arthritis
simple back pain
strains
muscle soreness

WARNINGS SECTION

For external use only

Do not use

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

you are allergic to any ingredients, PABA, aspirin products or sulfa

When using this product

avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

Store

at 20○C - 25○C (68○F - 77○F)

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 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

Please Email info@TerrainRX.com

Manufactured for
Terrain Pharmaceuticals
Reno, NV 89501

Made in the U.S.A.
Patent Pending

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

577-04577-04

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-577-04GM - Gram61919-577eedaa31d-4ae9-4cea-ba7b-e463e1c2a34812019-05-02
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
61919-57761919-577-04
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
0e870581-8be2-a386-e063-6394a90acd2a875fb4ec-d5f2-ad7f-e053-2995a90a6c402024-01-09WarningsExact identifier
spl set id: 875fb4ec-d5f2-ad7f-e053-2995a90a6c40

Reported adverse events (FAERS/openFDA)#

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