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| Product NDC Code | 63347-502 | ||||
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| Drug Name | Tineacide antifungal |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 998483, 1425352 |
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| Application Number | M005 | ||||
| Labeler Name | Blaine Labs 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 Drug Facts Active Ingredient Miconazole Nitrate 2%
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 Adult and children 2 years and older. Children under 2 years: ask physician. Wash the affected area with soap and water and dry thoroughly before applying. For athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 4 weeks (morning and night), or as directed by a physician.Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. For jock itch and ringworm apply twice daily to affected skin for 2 weeks or as directed by a physician. This product is not effective on the scalp or mails. Wash hands after each use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, lavandula Angustifolia Lavender Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, 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). Cures most jock inch (tinea cruris) and ring worm (tinea corporis). Relieves itching, burning, cracking, and scaling which accompany these conditions.
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.TINEACIDE Antifungal MICONAZOLE NITRATE MICONAZOLE NITRATE MICONAZOLE ALOE VERA LEAF CETYL ALCOHOL CLOTRIMAZOLE COCO-CAPRYLATE/CAPRATE EDETATE DISODIUM GLYCERYL MONOSTEARATE HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) LAVENDER OIL METHYLPARABEN PEG-100 STEARATE POLYSORBATE 60 PROPYLPARABEN STEARIC ACID TEA TREE OIL TROLAMINE UREA WATER
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 Dr. Blaine's TINEACIDE® Antifungal Cream Kills the skin fungus that causes fungal nails Treats mild to severe infections NET WT 1.25 OZ (35 g) 5 FUNGUS FIGHTERS NEW and IMPROVED FORMULATION 100% MONEY-BACK GUARANTEE! BONUS: Easy-Grip, Heavy-Duty Nail Clipper! EXP. Proudly made in the U.S.A.! Please Recycle! This package is made from recyclable materials. Questions or Comments? Call (800) 307-8818 Monday-Friday 8:00AM and 5:00PM (EST) Blaine Labs Inc. Santa Fe Springs, CA 90670 www.DrBlaines.com All rights reserved. res Blaine TINEACIDE5021 Label Blaine TINEACIDE502 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.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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Do not use if seal on bottle is broken or is not visible. Store between 2° and 30° C (36° and 85° F)
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 physician if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
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, do not get into the eyes. If eye contact occurs, rinse thoroughly with water.
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 in or near the mouth or eyes. Do not use for vaginal yeast infections.
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