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Product NDC Code | 83004-012 | ||||||||||
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Drug Name | Antifungal medicated body wash |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | GEL | ||||||||||
RxCUI drug identifier | 2689792 | ||||||||||
Application Number | M005 | ||||||||||
Labeler Name | Rida LLC | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Tolnaftate 1.0%
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 Make sure to dry affected area thoroughly. Supervise children in the use of this product. For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask 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 ingredients TETRASODIUM GLUTAMATE DIACETATE, EUCALYPTUS OIL, WATER, SODIUM GLUCONATE, SODIUM PALM KERNELATE, GLYCERIN, MELALEUCA ALTERNIFOLIA LEAF, SODIUM CHLORIDE, ACTIVATED CHARCOAL, SODIUM COCOATE, SODIUM PALMATE, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM COCOATE
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 treatment of most jock itch ringworm atheletes foot tinea versicolor Relieves itching scaling burning redness cracking associated discomfort
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.ANTIFUNGAL MEDICATED BODY WASH TOLNAFTATE TETRASODIUM GLUTAMATE DIACETATE EUCALYPTUS OIL WATER SODIUM GLUCONATE SODIUM PALM KERNELATE GLYCERIN MELALEUCA ALTERNIFOLIA LEAF SODIUM CHLORIDE ACTIVATED CHARCOAL SODIUM COCOATE SODIUM PALMATE SODIUM LAURETH SULFATE TOLNAFTATE TOLNAFTATE
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.Product label image description
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.Warning For external use only. When using this product When using this product avoid contact with the eye Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm. Do not use Do Not use on children under 2 under of age except under the advice and supervision of a doctor. 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