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Product NDC Code | 59208-002 | ||||||
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Drug Name | Cicloferon |
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Type | Brand | ||||||
Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | GEL | ||||||
RxCUI drug identifier | 1431682, 1431687 |
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Application Number | part348 | ||||||
Labeler Name | Laboratorios Liomont, S.A. de C.V. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Benzalkonium Chloride 0.13% Lidocaine Hydrchloride 2%
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 clean the affected area apply a small amount of this product to the affected area 1 to 3 times daily may be covered with a sterile bandage children under 12 years of age, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients hypromellose, methylparaben, propylene glycol, water, polysorbate 80
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 provides temporary relief of pain associated with cold sores and fever blisters first aid to help protect against infection in minor cuts, scrapes, burns
Purpose
Information about the drug product’s indications for use.Purpose Topical antiseptic Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.CICLOFERON benzalkonium chloride and lidocaine hydrochloride HYPROMELLOSE, UNSPECIFIED METHYLPARABEN PROPYLENE GLYCOL WATER POLYSORBATE 80 BENZALKONIUM CHLORIDE BENZALKONIUM LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS
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 Package Label
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 for more than 7 days unless told to do so by a doctor more than directed if you are allergic to any ingredient in this product
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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with the eyes
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at 20° to 25°C (68° to 77°F)
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: Do not use in the eyes or apply over large areas of the body. In case of deep puncture wounds, animal bites, or serious burns, consult a doctor.
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