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| Product NDC Code | 55505-193 | ||||
|---|---|---|---|---|---|
| Drug Name | Fungi nail anti-fungal pen |
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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 | Kramer Laboratories | ||||
| 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 Purpos e Tolnaftate 1% Anti-fungal
| Tolnaftate 1% | Anti-fungal |
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 affected area with soap and water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail ® Anti-Fungal over affected area twice daily (morning and night) or as directed by a doctor. ■ Wear well-fitting, ventilated shoes and change shoes and socks at least once daily. ■ For athlete's foot pay special attention to spaces between the toes. ■ For athlete's foot and ringworm, use daily for 4 weeks. ■ To prevent athlete's foot, apply once or twice daily (morning and/or night). ■ For toe fungus, apply under nail and cuticle area. If condition persists longer, consult a doctor. ■ The product is not effective on the scalp or nails. ■ Supervise children in the use of this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, tocopheryl acetate (vitamin E), xanthan gum, 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 ■ proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) ■ helps prevent most athlete's foot with daily use ■ for effective relief of itching, burning and cracking.
Purpose
Information about the drug product’s indications for use.Active Ingredient Purpos e Tolnaftate 1% Anti-fungal
| Tolnaftate 1% | Anti-fungal |
Spl product data elements
Usually a list of ingredients in a drug product.Fungi Nail Anti-Fungal Pen Tolnaftate Tolnaftate Tolnaftate Aloe Vera Leaf Ascorbic Acid Dimethicone Dmdm Hydantoin Edetate Disodium Eucalyptol Glycerin Glyceryl Stearate Se Lavender Oil Mineral Oil Olive Oil Peg-100 Stearate Phenoxyethanol Propylene Glycol Tea Tree Oil Titanium Dioxide .Alpha.-Tocopherol Acetate Xanthan Gum Water Carton Front Carton Back
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 Maximum Strength Medicine MAXIMUM STRENGTH FUNGI-NAIL ® ANTI-FUNGAL PEN CLINICALLY PROVEN TO CURE AND PREVENT FUNGAL INFECTIONS MAXIMUM STRENGTH FUNGI-NAIL ® PLUS Aloe & Tea Tree Oil TRIPLE ACTION FORMULA ✓ Kills Fungus ✓ Stops Itching & Burning ✓ Restores Skin Health + Cures Most Athlete's Foot PLUS Aloe & Tea Tree Oil CLINICALLY PROVEN INGREDIENT .101 FL OZ (3ml) FUNGI-NAIL ® Maximum Strength Anti-Fungal plus 5 Natural Oils: ○ aloe vera ○ lavender ○ tea tree ○ olive oil ○ eucalyptol and antioxidants Vitamin E and Vitamin C Fungi-Nail ® is Specially Formulated to Kill Fungus and Restore Skin Health Deep Penetrating Medicine that Stays in Place Convenient and Easy to Apply Pen Applicator Instructions for Use: Twist base with brush pointing upward to saturate brush. I f you do not hear a click, turn the other way. First time use may require several twists to initiate product flow. For best results treat around all toenails and in between toes. Not for nail or scalp fungus. Cures most athlete's foot. K0922 DO NOT USE IF NECKBAND IS BROKEN OR MISSING For more information about Fungi-Nail l® and money back guarantee, visit us at funginail.com KRAMER LABORATORIES Kramer Laboratories, Inc. Bridgewater, NJ 08807 1-800-824-4894
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 this and all medication out of the reach of children. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.
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.
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 eyes.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature 15°-30°C (59°-86°F). Protect from freezing. If freezing occurs warm to room temperature. Medicine may appear white to off white.
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
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