FDA.reportPublic FDA data

CMX Topical Pain Patch

Manufacturer
Unik Pharmaceuticals, Inc
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#

ProductCMX Topical Pain
Active ingredientMENTHOL, CAPSAICIN
Label structure7 sections

Indications and uses

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Dosage and administration

• Adults and children 12-years and over: Apply to affected area; change patch 1-2 times daily. • Children under 12, consult a physician before use. • How to Apply: • Clean and dry affected area. • Remove patch from backing and apply directly to area of pain. • Do not apply to affected area more than three times daily. • Use only on patch at a time. • Wash hands with soap and water immediately after application. • ...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.00%

Capsaicin 0.0375%

OTC - PURPOSE SECTION

Topical Analgesic

External Analgesic

Uses:

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

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 external heat source.
• Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar
device or garment.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Consult physician for children under 12.
• Do not use if allergic to Menthol.

Stop use and consult physician

OTC - STOP USE SECTION

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

• Stop use if itching to excessive skin irritation occurs.

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; change patch 1-2 times daily.
• Children under 12, consult a physician before use.
• How to Apply:
• Clean and dry affected area.
• Remove patch from backing and apply directly to area of pain.
• Do not apply to affected area more than three times daily.
• Use only on patch at a time.
• Wash hands with soap and water immediately after application.
• Reseal pouch containing unused patches.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Glycerin, Sodium Polyacrylate, Polysorbate-80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodium Salt, Diazolidinyl Urea, Methyl Paraben, Iodopropynyl Butylcarbamate, Propyl Paraben.

Store at room temperature.

SPL UNCLASSIFIED SECTION

Avoid direct sunlight

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PatchPatch

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69889-027-15EA - Each69889-0276803f32b-77fc-427f-b524-9f676b53e00c12016-12-07

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69889-02769889-027-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
PROPYLPARABENZ8IX2SC1OHIACT
MENTHOLL7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB

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
0721084a-0baf-58ce-e063-6294a90ac8423d924631-af49-42b0-e054-00144ff8d46c2023-10-07WarningsExact identifier
spl set id: 3d924631-af49-42b0-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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