Kofal Fuerte Ointment 2 oz

Manufacturer: Pharmadel LLC
Effective date: 2020-01-20
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 23:45:16

Label at a glance#

ProductKofal T

Active ingredientMETHYL SALICYLATE

Label structure9 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: consult a doctor

Contacts and useful links#

PhoneLabel contact1-866-359-3478

Websitewww.pharmadel.com

www.pharmadel.com

Label contents#

Full prescribing information#

Active ingredients & Purpose

OTC - PURPOSE SECTION

Purpose

External Analgesic

OTC - ACTIVE INGREDIENT 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 broken or irritated skin
with a tight bandage
with a heating pad

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
excessive skin irritation occurs

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: consult a doctor

Other information

OTHER SAFETY INFORMATION

store between 59° to 86°F (15° to 25°C)
do not use if seal over cap is broken, torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, menthol, methylparaben, paraffin wax, petrolatum, propylparaben.

Questions or comments?

OTC - QUESTIONS SECTION

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

Distributed by/ Distribuido por:

SPL UNCLASSIFIED SECTION

Pharmadel LLC, Georgetown, DE 199747

Package Label & Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KOFAL 2 OZ

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	3
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Kofal T
Methyl Salicylate
CAMPHOR (SYNTHETIC)
MENTHOL
METHYLPARABEN
PARAFFIN
PROPYLPARABEN
PETROLATUM
SALICYLIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55758-100	55758-100-02, 55758-100-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
MENTHOL	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PETROLATUM	4T6H12BN9U	IACT
METHYL SALICYLATE	LAV5U5022Y	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 202 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SOAP / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	AEROSOL, FOAM / TOPICAL		14235 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates

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
9225493b-1b6a-2e70-e053-2995a90a8eaa			d2cdaa04-3244-41b2-af5f-5bb37645bb43	2019-09-09	Warnings	Exact identifier spl set id: d2cdaa04-3244-41b2-af5f-5bb37645bb43

Reported adverse events (FAERS/openFDA)#

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