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| Product NDC Code | 70856-3581 | ||||
|---|---|---|---|---|---|
| Drug Name | Defense antifungal medicated bar |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOAP | ||||
| RxCUI drug identifier | 1807715 | ||||
| Application Number | M005 | ||||
| Labeler Name | Defense Soap LLC | ||||
| 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 Wash affected area well and let product sit 1-2 minutes before rinsing. 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 Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Acid, Sodium Chloride, Palm Kernel Acid, Charcoal Powder
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 effective in the treatment of most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris). For effective relief of itching, burning and cracking skin.
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.Defense Antifungal Medicated Bar Tolnaftate TETRASODIUM GLUTAMATE DIACETATE EUCALYPTUS OIL WATER SODIUM GLUCONATE SODIUM PALM KERNELATE GLYCERIN TOLNAFTATE TOLNAFTATE MELALEUCA ALTERNIFOLIA LEAF SODIUM CHLORIDE ACTIVATED CHARCOAL SODIUM COCOATE SODIUM PALMATE
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 Tolnaftate 1% Antifungal Medicated Bar Soap Cures and Prevents Most Fungal Skin Infections, Including Athlete’s Foot, Ringworm and Jock Itch. DEFENSE SOAP LLC, 3390 LIBERTY ATHENS AVE VERMILLION, OH 44089 866-544-1689 Carton
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 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
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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 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.
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 When using this product avoid contact with the eye
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 When using this product When using this product avoid contact with the eye Stop use and ask a doctor if 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. 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