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| Product NDC Code | 29784-181 | ||||
|---|---|---|---|---|---|
| Drug Name | Proclearz maximum strength fungal shield brush-on antifungal |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 313423, 1311221 |
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| Application Number | M005 | ||||
| Labeler Name | Profoot, 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 ■ shake well before using ■ wash affected area and dry thoroughly ■ apply a thin layer of the product over affected area (around the nails and underneath nail tips) twice daily or as directed by a doctor ■ supervise children in the use of this product ■ for athlete’s foot, pay special attention to spaces between the 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 ingredients Acetone, Aloe Vera (Aloe Barbadensis) Gel, Propylene Glycol, Tocopherol Acetate (Vitamin E), Water
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 cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete's foot from recurring when used daily relieves itching, scaling, cracking, burning, and redness
Purpose
Information about the drug product’s indications for use.Purpose Anti-fungal
Spl product data elements
Usually a list of ingredients in a drug product.ProClearz Maximum Strength Fungal Shield Brush-on Antifungal Tolnaftate ACETONE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE PROPYLENE GLYCOL WATER 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.updated outer box Drug Facts Panel Upated Inner Label
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.If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children.
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 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 if contact occurs rinse thoroughly with water
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at room temperature 15º-30ºC (59º-86ºF)
General precautions
Information about any special care to be exercised for safe and effective use of the drug.Extremely flammable keep away from fire or flame
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
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