Drug Facts
Drug Facts
Kofal Original Ointment
FDA Label NDC 55758-108
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 Original (NDC 55758-108). 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 drug facts, otc - purpose, use, warnings, do not, stop use and ask a doctor 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
Otc - Purpose
| Active ingredient | Purpose |
| Mythyl Salicylate 12%........................................ | Topical Analgesic |
Use
For the temporary relief of minor aches and pains of muscles and joints associated with
- backaches
- arthritis
- strains
- bruises
- sprains
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.
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
Other Information
- store in a cool dry place between (59-86°F)15-30°C
- don’t use if seal over cap is broken, torn, or missing
Inactive Ingredients
camphor, cetyl alcohol, eucalyptus oil, glyceryl monostearate, menthol, methylparaben, paraffin, propylene glycol, propylparaben,
stearic acid, triethanolamine, wate
Principal Display Panel
KOFAL ® Original
Penetrating pain relieving ointment
Pomada analgesica con accion penetrante
4 oz (113 g)
* Please review the disclaimer below.
