Drugplain

Kofal Fuerte 15 g/100g

Methyl Salicylate · OINTMENT · Pharmadel LLC

No Recall History
Plain English

Kofal Fuerte is a ointment containing methyl salicylate at 15 g/100g, taken topical. Manufactured by Pharmadel LLC.

Key Facts

Brand Name
Kofal Fuerte
Generic Name
Methyl Salicylate
NDC Code (Product)
55758-107
Manufacturer
Pharmadel LLC
Strength
15 g/100g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Application #
M017
Marketing Start
12/03/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pruritus58 reports
drug ineffective47 reports
pneumonia47 reports
hypertension46 reports
dyspepsia42 reports
off label use41 reports
rheumatoid arthritis40 reports
urosepsis40 reports
angioedema39 reports
drug intolerance39 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use For the temporary relief of minor aches and pains of muscles and joints associated with backaches arthritis strains bruises sprains

Dosage & Administration

Directions 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

Warnings

Warnings For external use only. Avoid contact with the eyes Do not apply to wounds or damaged skin bandage tightly Stop use and ask a doctor if 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, ask a health professional before use. Keep out of reach of children If swallowed, get medical help, or contact a Poison Control Center immediately.

Frequently Asked Questions

What is Kofal Fuerte used for?

Kofal Fuerte contains Methyl Salicylate. It is a ointment taken topical. Consult your doctor for specific uses.

Is Kofal Fuerte a controlled substance?

Kofal Fuerte is not classified as a controlled substance by the DEA.

What is the generic name for Kofal Fuerte?

The generic name for Kofal Fuerte is Methyl Salicylate. There are 12 other brand versions of Methyl Salicylate.

What is the NDC code for Kofal Fuerte 15 g/100g?

The NDC (National Drug Code) for Kofal Fuerte 15 g/100g is 55758-107, listed by Pharmadel LLC.