Kofal Fuerte - Pharmadel LLC

Manufacturer: Pharmadel LLC
Effective date: 2026-03-26
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:51:44

Label at a glance#

ProductKofal Fuerte

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

Storage and handling

store in a cool dry place between (59-86°F)15-30°C don’t use if seal over jar is broken, torn, or missing

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient	Purpose
Mythyl Salicylate 15%	Topical analgesic

Use

INDICATIONS & USAGE SECTION

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

backaches
arthritis
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

Other information

STORAGE AND HANDLING SECTION

store in a cool dry place between (59-86°F)15-30°C
don’t use if seal over jar is broken, torn, or missing

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KOFAL ® Fuerte

Deportistas - Athletes

Pain relieving ointment

Pomada analgesico

4 oz (113 g)

PDP Kofal 4 Oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2260510	methyl salicylate 15 % Topical Ointment	PSN	7
2260510	methyl salicylate 0.15 MG/MG Topical Ointment	SCD	7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-107-04	Kofal Fuerte	113 g in 1 JAR	OINTMENT	113		7

Products#

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

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55758-107	55758-107-04

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
POLYSORBATE 20	7T1F30V5YH	IACT
METHYL SALICYLATE	LAV5U5022Y	ACTIB
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
TROLAMINE	9O3K93S3TK	IACT
PARAFFIN	I9O0E3H2ZE	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
STEARIC ACID	4ELV7Z65AP	IACT
CAMPHOR, (-)-	213N3S8275	IACT
CETYL ALCOHOL	936JST6JCN	IACT
METHYLPARABEN	A2I8C7HI9T	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
6	2025-12-04	monthly-update	2026-06-03 17:45:26

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 Fuerte	METHYL SALICYLATE	Pharmadel LLC	98488a07-eba0-2b4e-e053-2995a90ad6ab	2026-03-26	Warnings	Exact identifier ndc (package): 55758-107-04 ndc (product): 55758-107 ndc11 (package): 55758010704 spl id: 4df1c20b-2971-53dd-e063-6394a90a569d spl set id: 98488a07-eba0-2b4e-e053-2995a90ad6ab

Reported adverse events (FAERS/openFDA)#

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