FDA.reportPublic FDA data

Kofal-T Original

Manufacturer
PHARMADEL LLC
Effective date
2019-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:02:58

Label at a glance#

ProductKofal-T Original
Active ingredientMETHYL SALICYLATE
Label structure7 sections

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Mythyl Salicylate 12%........................................Topical Analgesic

Use

INDICATIONS & USAGE SECTION

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

  • arthritis
  • backaches
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes

Do not

OTC - DO NOT USE SECTION

  • apply to wounds or damaged skin
  • bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if 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 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 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, cetyl alcohol, eucalyptus oil, glyceryl monostearate, menthol, methylparaben, paraffin, propylene glycol, propylparaben,
stearic acid, triethanolamine, wate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KOFAL - T® Original

Penetrating pain relieving ointment - Pomada analgesica con accion penetrante

4 oz (113 g)

KOFAL-T ORIGINALKOFAL-T ORIGINAL

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-10655758-106-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
PARAFFINI9O0E3H2ZEIACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOLL7T10EIP3AIACT
STEARIC ACID4ELV7Z65APIACT
CAMPHOR OIL75IZZ8Y727IACT
CETYL ALCOHOL936JST6JCNIACT

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
98487631-e19f-12a9-e053-2a95a90ac9e3825abc03-a659-515c-e053-2a91aa0a1c0a2019-11-26WarningsExact identifier
spl set id: 825abc03-a659-515c-e053-2a91aa0a1c0a

Reported adverse events (FAERS/openFDA)#

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