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| Product NDC Code | 55758-109 | ||||
|---|---|---|---|---|---|
| Drug Name | Kofal |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1101920, 2273244 |
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| 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 Purpose Methyl Salicylate 10.5%............................. External Analgesic
| Methyl Salicylate 10.5%............................. | External 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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients camphor, menthol, methylparaben, paraffin, petrolatum, propylparaben.
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.Uses For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains sprains
Purpose
Information about the drug product’s indications for use.Active ingredients & Purpose Purpose External Analgesic Active ingredient Purpose Methyl Salicylate 10.5%............................. External Analgesic
| Methyl Salicylate 10.5%............................. | External Analgesic |
Spl product data elements
Usually a list of ingredients in a drug product.Kofal Methyl Salicylate CAMPHOR, (-)- MENTHOL, UNSPECIFIED FORM METHYLPARABEN PARAFFIN PROPYLPARABEN PETROLATUM METHYL SALICYLATE SALICYLIC ACID
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.Package Label & Principal Display Panel PDP Kofal 2oz
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.Distributed by/ Distribuido por: Pharmadel LLC, Georgetown, DE 199747
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 use on broken or irritated skin with a tight bandage with a heating pad
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 59° to 86°F (15° to 25°C) do not use if clear seal over jar is broken, torn or missing
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-359-3478 M-F 9 AM - 5 PM EST or www.pharmadel.com
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 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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health care professional before use.
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 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.
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