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| Product NDC Code | 56104-900 | ||||
|---|---|---|---|---|---|
| Drug Name | Maximum strength antifungal liquid |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 313423 | ||||
| Application Number | M005 | ||||
| Labeler Name | Premier Brands of America 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% w/w
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 wash the affected area and dry thoroughly. apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. supervise children in the use of this product. 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 condition persists longer, consult a doctor. this product is not effective on the scalp or nails.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Acetone, Water, Propylene Glycol, Tocopherol Acetate.
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 treament of athlete's foot (tinea pedis) and ring worm (tinea corporis). For effective relief of itching, scaling, cracking, burning, and redness.
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.Maximum Strength Antifungal Liquid Tolnaftate WATER TOCOPHEROL TOLNAFTATE TOLNAFTATE ACETONE PROPYLENE GLYCOL
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 premier solutions MAXIMUM STRENGTH ANTIFUNGAL LIQUID TOLNAFTATE 1%/ANTIFUNGAL SHAKE WELL BEFORE USE Maximum strength Cures & prevents athlete's foot Brush-on applicator Treats fungus on skin & under the nails 1.0 FL OZ (30 mL) Box Label
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.Flammable Keep away from fire or flame.
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.
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 15°-30°C (59° - 86°F). keep tightly closed when not in use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-866-964-0939
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 or if there is no improvement in 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 the 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. Flammable Keep away from fire or flame. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes. Stop use and consult a doctor if irritation occurs or if there is no improvement in 4 weeks. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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