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| Product NDC Code | 63347-810 | ||||
|---|---|---|---|---|---|
| Drug Name | Vite20 |
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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 | LIQUID | ||||
| RxCUI drug identifier | 998525 | ||||
| Application Number | M005 | ||||
| Labeler Name | Blaine Labs Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.DRUG FACTS Active Ingredient Miconazole Nitrate 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 Was the affected area with soap and water, dry thorougly, then apply sparingly over the affected area. Use twice daily (morning and night) or as directed by a physician Supervise children in the use of this product For Athlete's Foot and Ringworm, use daily for four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician Wash hands after each use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Isopropyl Alcohol, Deionized Water, Triethanokamine, Glycerin, Hydroxypropylcelluose, Tocopheryl Acetate, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben, Phenoxyethanol
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.INDICATIONS Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis) Relieves Itching, cracking, burning and scaling. which accompany these conditions Prevents most Athlete's Foot with daily use
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Vite20 MICONAZOLE NITRATE MICONAZOLE NITRATE MICONAZOLE ISOPROPYL ALCOHOL WATER TROLAMINE GLYCERIN HYDROXYPROPYL CELLULOSE, UNSPECIFIED .ALPHA.-TOCOPHEROL ACETATE METHYLPARABEN ETHYLPARABEN PROPYLPARABEN BUTYLPARABEN ISOBUTYLPARABEN PHENOXYETHANOL
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.Vite20 product label VITÉ 20 BRUSH - ON NDC# 63347-810-01 Vité20® BRUSH-ON KILLS FUNGUS Maxium Strength Professional Formula 15 mL (0.5 FL OZ) SEE SIDE PANEL FOR MORE INFORMATION KILLS FUNGUS *Made in the U.S.A. Questions or Comments? Call 800-307-8818 M-F 7:00 am - 5:00 pm PST www.vite20.com Manufactured by: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670 Please recycle! This package is made from recyclable materials 06100-p-bx01 res Vite20 - 810
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. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at room temperature
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 consult a physician if irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch)
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. If contact occurs, rinse thoroughly with water.
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 : On children under two (2) years of age unless directed by a physician In or near the mouth or the eyes For vaginal yeast infections
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