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| Product NDC Code | 52083-242 | ||||
|---|---|---|---|---|---|
| Drug Name | Myco nail a antifungal solution |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 998329 | ||||
| Application Number | part333C | ||||
| Labeler Name | Kramer Novis | ||||
| 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 Undecylenic Acid 25% v/v
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 and dry thoroughly. Apply a thin layer of Myco Nail A over the affected area twice daily (morning and night) or as directed by a physician. Supervise children in the use of this product. For athlete's foot: pay special attention to spaces between toes; wear well-fitted, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a physcian.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Benzyl acetate, benzyl alcohol, cetylpyridinium chloride, chloroxylenol, eucalyptol, glacial acetic acid, Isopropyl alcohol, propionic acid, propylene glycol, sodium propionate and triacetin.
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 treatment of athlete's foot (tinea pedis), ringworm (tinea corporis). For effective relief of itching, irritation, and burning feet.
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.Myco Nail A Antifungal Solution Undecylenic acid UNDECYLENIC ACID UNDECYLENIC ACID BENZYL ACETATE BENZYL ALCOHOL CETYLPYRIDINIUM CHLORIDE CHLOROXYLENOL EUCALYPTOL ACETIC ACID ISOPROPYL ALCOHOL PROPIONIC ACID PROPYLENE GLYCOL SODIUM PROPIONATE TRIACETIN
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 - 30ml Bottle Carton Myco Nail A ® Antifungal Solution Topical Formula 1 Fl. Oz. 30 ml. MANUFACTURED IN USA FOR KRAMER-NOVIS San Juan, P.R. 00918 PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
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.Drug Facts
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 physician.
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. If you are pregnant or breast-feeding consult a health care professional before using this product.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or omments: Kramer Novis, San Juan PR, 1-787-767-2072
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 and mucuos membranes. Stop use and ask a doctor if irritation occurs or is there is no improvement within 4 weeks.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 15 - 30 C (50 – 86F). Do not accept if safety seal is broken or missing.
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. Flammable: Keep away from fire and flame. Do not use on children under 2 years of age unless directed by a physician. When using this product avoid contact with the eyes and mucuos membranes. Stop use and ask a doctor if irritation occurs or is there is no improvement within 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If you are pregnant or breast-feeding consult a health care professional before using this product.
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