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| Product NDC Code | 76348-401 | ||||||
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| Drug Name | Molecular af |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OIL | ||||||
| RxCUI drug identifier | 1362937, 1362942 |
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| Application Number | M005 | ||||||
| Labeler Name | Renu Laboratories, 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.Active Ingredient Tolnaftate 1%
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 over the affected area twice daily (morning and night) supervise children in the use of the product for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks, if condition lasts longer, ask a doctor to prevent athlete's foot, apply to the feet once or twice daily this product is not effective on the scalp or nails
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.CITRIC ACID MONOHYDRATE, DIETHYLENE GLYCOL MONOETHYL ETHER, ETHYL MACADAMIATE OLIVE OIL, POTASSIUM SORBATE, TEA TREE OIL
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 proven clinically to cure most: athlete's foot (tinea pedis) ringworm (tinea corporis) effectively soothes and relieves: itching burning cracking helps prevent most athlete's foot from coming back 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.Molecular AF tolnaftate CINNAMON OIL CITRIC ACID MONOHYDRATE POTASSIUM SORBATE ETHYL MACADAMIATE TOLNAFTATE TOLNAFTATE DIETHYLENE GLYCOL MONOETHYL ETHER TEA TREE OIL OLIVE OIL
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.Version 2_Molecular_AF_Oil Molecular AF_Dynamic_Oil_Box
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.There are no changes
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 there is no improvement within 4 weeks
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.www.MolecularAF.com 888-919-1818
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 irritation occurs there is no improvement within 4 weeks
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 68º - 77º (20º - 25º C)
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 2 years of age unless directed by a doctor When using this product avoid contact with the eyes
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