Kofal - 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

Active ingredientMETHYL SALICYLATE

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 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

Contacts and useful links#

PhoneLabel contact+1-866-359-3478

Websitewww.pharmadel.com

www.pharmadel.com

Label contents#

Full prescribing information#

Active Ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient Purpose

Methyl salicylate 10.5%....................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
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.

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, D&C yellow #11, lanolin, menthol, paraffin, petrolatum, propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

+1-866-359-3478 M-F 9 AM - 5 PM EST or www.pharmadel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP KOFAL RED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2273244	KOFAL 10.5 % Topical Ointment	PSN	7
1101920	methyl salicylate 10.5 % Topical Ointment	PSN	7
2273244	methyl salicylate 0.105 MG/MG Topical Ointment [Kofal]	SBD	7
1101920	methyl salicylate 0.105 MG/MG Topical Ointment	SCD	7
2273244	Kofal 0.105 MG/MG Topical Ointment	SY	7
1101920	methyl salicylate 10.5 % Topical Ointment	SY	7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-109-02	Kofal	60 g in 1 JAR	OINTMENT	60		7

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Kofal
Methyl Salicylate
CAMPHOR, (-)-
MENTHOL, UNSPECIFIED FORM
D&C YELLOW NO. 11
PARAFFIN
PROPYLPARABEN
PETROLATUM
SALICYLIC ACID
LANOLIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55758-109	55758-109-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAMPHOR, (-)-	213N3S8275	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
D&C YELLOW NO. 11	44F3HYL954	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PETROLATUM	4T6H12BN9U	IACT
METHYL SALICYLATE	LAV5U5022Y	ACTIB
LANOLIN	7EV65EAW6H	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 17:45:23

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	METHYL SALICYLATE	Pharmadel LLC	9cac377d-97bc-f0b7-e053-2a95a90a2e12	2026-03-26	Warnings	Exact identifier ndc (package): 55758-109-02 ndc (product): 55758-109 ndc11 (package): 55758010902 spl id: 4df1cbb9-f4cc-64ca-e063-6394a90a4286 spl set id: 9cac377d-97bc-f0b7-e053-2a95a90a2e12

Reported adverse events (FAERS/openFDA)#

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