FDA.reportPublic FDA data

MTX Topical Pain Patch

Manufacturer
Unik Pharmaceuticals, Inc. | Pure Source, LLC
Effective date
2017-02-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:19:46

Label at a glance#

ProductMTX Topical Pain
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure7 sections

Indications and uses

For temporary relief of pain and itching associated with minor burns, cuts, scrapes and minor skin irritations.

Dosage and administration

• Adults and children 12-years and over: Apply to affected area. • Children under 12: consult a physician before use. • How to Apply: • Clean and dry affected area. • Remove patch from backing and apply directly to affected area. • Use only one patch at a time, and maximum of four patches per day. • Leave patch on affected area for up to 8-hours. • Do not use patches for longer than five consecutive days.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4.00%

Menthol 1.00%

OTC - PURPOSE SECTION

Topical Analgesic

External Analgesic

Uses:

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with minor burns, cuts, scrapes and minor skin irritations.

Warnings:

WARNINGS SECTION

• For external use only. Use only as directed.
• Avoid contact with eyes and mucous membranes.
• Do not apply to open wounds or damaged skin.

Do not use

OTC - DO NOT USE SECTION

• in combination with any other external analgesic products..

• Do not use with any bandage, wrap, stocking or similar device or garment.

• If symptoms persist for more than 7 days, discontinue use and consult a physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Children under 12 should consult physician prior to use.
• If swallowed, consult a physician
• Do not bandage tightly.

Stop use and consult physician

OTC - STOP USE SECTION

• if symptoms worsen or persist for more than 7 days.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

• contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12-years and over: Apply to affected area.
• Children under 12: consult a physician before use.
• How to Apply:
• Clean and dry affected area.
• Remove patch from backing and apply directly to affected area.
• Use only one patch at a time, and maximum of four patches per day.
• Leave patch on affected area for up to 8-hours.
• Do not use patches for longer than five consecutive days.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbate-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5.

Store at room temperature.

SPL UNCLASSIFIED SECTION

  • Avoid direct sunlight

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Patch2Patch2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69889-026-15EA - Each69889-0269d20e6bc-cbb4-4a64-9d8d-e275d6ae0ab712016-12-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69889-02669889-026-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TROLAMINE9O3K93S3TKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB

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
0742f20d-a498-e96f-e063-6394a90a03a33d924631-af59-42b0-e054-00144ff8d46c2023-10-09WarningsExact identifier
spl set id: 3d924631-af59-42b0-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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