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| Product NDC Code | 72127-0806 | ||||
|---|---|---|---|---|---|
| Drug Name | Forticept antifungal foot gel |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1049535 | ||||
| Application Number | part333C | ||||
| Labeler Name | Lidan, Inc. | ||||
| 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.DRUG FACTS Active Ingredient/Purpose Clotrimazole - 1% (Antifungal)
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: • wash affected area and dry thoroughly • apply a thin layer over affected area once or twice daily • supervise children in the use of this product • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated • shoes and change socks at least once daily • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks • if condition persists longer, ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Allantoin, Alpha Tocopherol, Benzethonium Chloride, Cetosearyl Alcohol, Aluminum Starch Octenylsuccinate, Ethylhexylglycerin, Hexamethyldisilazane, Isohexadecane, Lanolin, Paraffinum Liquidum, Peppermint Oil, Petrolatum, Phenoxyethanol, Polyhexanide, Polysorbate 80, Propylene Glycol, Shea Butter, Sodium Acrylate / Sodium Acryloyldimethyl Taurate Copolymer, Steareth-2, Steareth-21, Tea Tree Oil, Thymol, 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.For the treatment of fungal infections caused by: Athlete's foot (tinea pedis), Jock itch (tinea cruris), and Ringworm (tinea corporis)
Purpose
Information about the drug product’s indications for use.Uses • Cures most athlete's foot, jock itch and ringworm • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions • Helps keep feet dry and free of fungal infection For the treatment of fungal infections caused by: Athlete's foot (tinea pedis), Jock itch (tinea cruris), and Ringworm (tinea corporis)
Spl product data elements
Usually a list of ingredients in a drug product.Forticept Antifungal Foot Gel Clotrimazole CLOTRIMAZOLE CLOTRIMAZOLE ALLANTOIN .ALPHA.-TOCOPHEROL ALUMINUM STARCH OCTENYLSUCCINATE BENZETHONIUM CHLORIDE CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN HEXAMETHYLDISILAZANE ISOHEXADECANE LANOLIN MINERAL OIL TEA TREE OIL PEPPERMINT OIL PETROLATUM PHENOXYETHANOL POLIHEXANIDE POLYSORBATE 80 PROPYLENE GLYCOL SHEA BUTTER SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) Steareth-2 STEARETH-21 THYMOL WATER
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.3oz label
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.Other Information: • To open: unscrew cap and remove the seal. • Store between 68° - 77°F (20° - 25°C)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if: • irritation occurs • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).
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 children under 2 years of age unless directed by a doctor.
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 right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.For Questions: Please call: +1 212 709-8133 Lidan, Inc. 30 Wall Street, 8th Floor New York, NY 10005 www.forticept.com
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 eyes.
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!
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