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| Product NDC Code | 55758-108 | ||||
|---|---|---|---|---|---|
| Drug Name | Kofal original |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| Application Number | M017 | ||||
| Labeler Name | Pharmadel LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient and Purpose Active ingredient Purpose Mythyl Salicylate 12%........................................ Topical Analgesic
| Mythyl Salicylate 12%........................................ | Topical Analgesic |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients camphor, cetyl alcohol, eucalyptus oil, glyceryl monostearate, menthol, methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, trolamine, water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use For the temporary relief of minor aches and pains of muscles and joints associated with backaches arthritis strains bruises sprains
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose Mythyl Salicylate 12%........................................ Topical Analgesic
| Mythyl Salicylate 12%........................................ | Topical Analgesic |
Spl product data elements
Usually a list of ingredients in a drug product.Kofal Original Methyl Salicylate METHYL SALICYLATE SALICYLIC ACID GLYCERYL MONOSTEARATE PROPYLENE GLYCOL PROPYLPARABEN WATER TROLAMINE METHYLPARABEN PARAFFIN EUCALYPTUS OIL MENTHOL, UNSPECIFIED FORM STEARIC ACID CAMPHOR OIL CETYL ALCOHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel KOFAL ® Original Penetrating pain relieving ointment Pomada analgesica con accion penetrante 4 oz (113 g) PDP Kofal Blue 4 Oz
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts Drug Facts
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not apply to wounds or damaged skin bandage tightly
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed, get medical help, or contact a Poison Control Center immediately.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store in a cool dry place between (59-86°F)15-30°C don’t use if clear seal over jar is broken, torn, or missing
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API