Kofal Ointment
FDA Label NDC 55758-109

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Kofal (NDC 55758-109). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients & purpose, otc - active ingredient, uses, warnings, do not use, stop use and ask doctor immediately if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients & Purpose

Purpose

External Analgesic

Otc - Active Ingredient

Active ingredient Purpose
Methyl Salicylate 10.5%.............................External Analgesic

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only. Avoid contact with the eyes.

Do Not Use

  • on broken or irritated skin
  • with a tight bandage
  • with a heating pad

Stop Use And Ask Doctor Immediately If

  • 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,

ask a health care professional before use.

Keep Out Of Reach Of Children.

If swallowed get medical help, or contact a Poison Control Center immediately.

Directions

  • 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

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

Inactive Ingredients

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

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