FDA.reportPublic FDA data

CMC Pain Relieving Patch

Manufacturer
Unexo Life Sciences, Private Limited
Effective date
2020-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:37

Label at a glance#

ProductCMC Pain Relieving
Active ingredient.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR, MENTHOL, UNSPECIFIED FORM, CAPSAICIN
Label structure10 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with: Simple backaches Arthritis Strains Sprains

Dosage and administration

Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily Children under 12 years of age consult a doctor clean and dry affected area remove patch from film apply sticky side of patch to affected area use one patch at a time leave patch on affected area for up to 8 hours at a time

Storage and handling

Store at room temperature 59-86°F (15-30°C) Do not store in direct sunlight or expose to excessive heat TAMPER EVIDENT: Do not use if packet containing the patch is torn or broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredient
Camphor 3%External Analgesic
Menthol 1.25%External Analgesic
Capsaicin 0.025%External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backaches
  • Arthritis
  • Strains
  • Sprains

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

  • On wounds or damaged skin
  • With a bandage or heating pad
  • On sensitive skin
  • if allergic to any ingredient in this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • symptoms persist for more than 7 days
  • clear up and occur again within a few days
  • redness is present

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • Children under 12 years of age consult a doctor
  • clean and dry affected area
  • remove patch from film
  • apply sticky side of patch to affected area
  • use one patch at a time
  • leave patch on affected area for up to 8 hours at a time

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature 59-86°F (15-30°C)
  • Do not store in direct sunlight or expose to excessive heat

TAMPER EVIDENT: Do not use if packet containing the patch is torn or broken

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Adhesive plaster

Questions

OTC - QUESTIONS SECTION

Call +91 9212228401

SPL UNCLASSIFIED SECTION

Manufactured By:
UNEXO LIFE SCIENCES PVT. LTD.
B-16. Sector 4, Bawana Industrial Area,
Delhi – 110039 (INDIA)

PRINCIPAL DISPLAY PANEL - 6 Pouch Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 71391-125-06

UNEXO's
PAIN RELIEVING
HOT PATCH

External Analgesic

Penetrating pain relief for:

  • Back Aches
  • Muscles
  • Arthritis

6
Adhesive Plaster Patches
4.72 in x 7.07 in (12 cm x 18 cm)

PRINCIPAL DISPLAY PANEL - 6 Pouch Box
PRINCIPAL DISPLAY PANEL - 6 Pouch Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71391-125-012022-01-28C16284748780-1d6a99b39-e1db-a426-e053-dadaa90af4c2CMC Pain Relieving Patch
71391-125-062022-01-28C16284748780-1d6a99b39-e1db-a426-e053-dadaa90af4c2CMC Pain Relieving Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71391-125-01CMC Pain Relieving1 in 1 POUCHPATCH11
71391-125-06CMC Pain Relieving6 in 1 BOXPATCH61
71391-125-06CMC Pain Relieving1 in 1 POUCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71391-125CMC PAIN RELIEVING (.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR, MENTHOL, UNSPECIFIED FORM, AND CAPSAICIN) PATCH [UNEXO LIFE SCIENCES, PRIVATE LIMITED]1Legacy NDC, 3 package rows20200903_4bf629d1-f43a-4496-8ff5-79df53d18235.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71391-12571391-125-01, 71391-125-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHORF89Z8SAG3OACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
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
87bd3975-764f-4a46-8865-028847881f974bf629d1-f43a-4496-8ff5-79df53d182352020-05-26WarningsExact identifier
spl id: 87bd3975-764f-4a46-8865-028847881f97
spl set id: 4bf629d1-f43a-4496-8ff5-79df53d18235

Reported adverse events (FAERS/openFDA)#

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