Kofal Original - Pharmadel LLC

Manufacturer: Pharmadel LLC
Effective date: 2026-03-26
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:51:44

Label at a glance#

ProductKofal Original

Active ingredientMETHYL SALICYLATE

Label structure7 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 and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient Purpose

Methyl salicylate 12%...........................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 use

OTC - DO NOT USE SECTION

on wounds or damaged skin

When using this product

OTC - WHEN USING SECTION

do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 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 seal over cap is broken, torn, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, cetostearyl alcohol, eucalyptus oil, glyceryl monostearate, menthol, methylparaben, paraffin, polysorbate 20, propylparaben, stearic acid, trolamine, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP KOFAL AZUL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2260507	methyl salicylate 12 % Topical Ointment	PSN	8
2260507	methyl salicylate 0.12 MG/MG Topical Ointment	SCD	8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-108-04	Kofal Original	113 g in 1 JAR	OINTMENT	113		8

Products#

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

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

Kofal Original
Methyl Salicylate
SALICYLIC ACID
POLYSORBATE 20
GLYCERYL MONOSTEARATE
PROPYLPARABEN
WATER
TROLAMINE
METHYLPARABEN
PARAFFIN
EUCALYPTUS OIL
MENTHOL, UNSPECIFIED FORM
STEARIC ACID
CAMPHOR, (-)-
CETOSTEARYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55758-108	55758-108-04

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
Name	UNII	Kind
METHYL SALICYLATE	LAV5U5022Y	ACTIB
POLYSORBATE 20	7T1F30V5YH	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
TROLAMINE	9O3K93S3TK	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PARAFFIN	I9O0E3H2ZE	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
STEARIC ACID	4ELV7Z65AP	IACT
CAMPHOR, (-)-	213N3S8275	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2025-12-04	monthly-update	2026-06-03 17:45:23

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kofal Original	METHYL SALICYLATE	Pharmadel LLC	984780fd-496b-150b-e053-2995a90aed77	2026-03-26	Warnings	Exact identifier ndc (package): 55758-108-04 ndc (product): 55758-108 ndc11 (package): 55758010804 spl id: 4df19cc8-4453-059a-e063-6394a90a289e spl set id: 984780fd-496b-150b-e053-2995a90aed77

Reported adverse events (FAERS/openFDA)#

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