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| Product NDC Code | 68016-474 | ||||
|---|---|---|---|---|---|
| Drug Name | Premier value antifungal maximum strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M005 | ||||
| Labeler Name | PHARMACY VALUE ALLIANCE, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Undecylenic Acid 25%
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 Read all warnings and directions. ▪ Read all package directions and warnings before use ▪ Use only as directed ▪ clean the affected area with soap and warm water and dry thoroughly ▪ Apply a thin layer of this product over affected area twice daily (morning and night) or as directed by a doctor. ▪ The brush applicator allows for easy application under nails and surrounding cuticle area. ▪ wear well-fitting, ventilated shoes, and change shoes and socks at least once daily ▪ this product is not effective on the scalp or nails ▪ for athlete's foot: pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. ▪ For athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult a doctor ▪ Intended for use by normally healthy adults only ▪ Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor ▪ Supervise children in the use of this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Isopropyl palmitate
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 cure of most: ▪ ringworm (tinea corporis) ▪ athlete’s foot (tinea pedis) ▪ itching ▪ scaling ▪ cracking ▪ burning ▪ redness ▪ soreness ▪ irritation ▪ discomfort which may accompany these conditions.
Purpose
Information about the drug product’s indications for use.Purpose Anti-fungal
Spl product data elements
Usually a list of ingredients in a drug product.Premier Value Antifungal Maximum Strength Undecylenic Acid UNDECYLENIC ACID UNDECYLENIC ACID ISOPROPYL PALMITATE
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 NDC 68016-474-00 COMPARE TO THE ACTIVE INGREDIENT FUNGICURE® MAXIMUM STRENGTH Anti-Fungal Liquid • Topical formula for toe and foot • Cures and Heals athlete’s foot fungus and ringworm • Helps relieves related discomforts 1 FL OZ (30mL) IMPORTANT: KEEP this carton for future reference on full labeling Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 *This product is not manufactured or distributed by ALVA-AMCO Pharmacal Cos., Inc., the distributor of Fungi Cure® Premier Value Max Str Anti Fungal Liquid
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.Ask a doctor before use On children under 2 years of age
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 right away at 1-800-222-1222.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • This product may be applied to exposed nail-beds to cuticles, around nail edges and under nail tips where reachable with its applicator brush • This product is not intended to, nor will it, penetrate hard nail surfaces • While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use this product until satisfactory results are obtained. • store at room temperature. Keep the container tightly closed when not in use. • Store away from excessive heat and cold.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-866-467-2748
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 doctor if ▪ irritation occurs ▪ there is no improvement within 4 weeks
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 Ask a doctor before use On children under 2 years of age When using this product avoid contact with eyes Stop use and consult a doctor if ▪ irritation occurs ▪ there is no improvement within 4 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away at 1-800-222-1222.
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