FDA.reportPublic FDA data

Kofal Max Power - Pharmadel LLC

Manufacturer
Pharmadel LLC
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:51:47

Label at a glance#

ProductKofal Max Power
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

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

Dosage and administration

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a doctor

Label contents#

Full prescribing information#

Active ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Menthol 1.25% ..................External analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not

OTC - DO NOT USE SECTION

  • apply on wounds or irritated skin
  • bandage tightly

Stop use and ask doctor immediately if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store between 59°- 86°F (15 - 30°C)
  • do not use if clear seal over jar is broken, torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, arnica montana flower, cannabis sativa (hemp) seed oil, camphor, carbomer 940, DMDM hydantoin, eucalyptus oil, isopropyl alcohol, nonoxynol-9, polysorbate 20, propylene glycol, tea tree oil, trolamine, water

Distributed by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kofal MP PDPKofal MP PDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-376-05KofalMax Power142 g in 1 JAROINTMENT1424

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-37655758-376-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
NONOXYNOL-948Q180SH9TIACT
POLYSORBATE 207T1F30V5YHIACT
TEA TREE OILVIF565UC2GIACT
DMDM HYDANTOINBYR0546TOWIACT
ISOPROPYL ALCOHOLND2M416302IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-04monthly-update2026-06-03 17:45:20

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
Kofal Max PowerMENTHOLPharmadel LLCfe1f1408-b0cb-67a4-e053-6394a90ad6092026-03-26WarningsExact identifier
ndc (package): 55758-376-05
ndc (product): 55758-376
ndc11 (package): 55758037605
spl id: 4df1c70f-4fc7-55f4-e063-6394a90aeee1
spl set id: fe1f1408-b0cb-67a4-e053-6394a90ad609

Reported adverse events (FAERS/openFDA)#

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