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Product NDC Code | 63347-511 | ||||
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Drug Name | Tineacide |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
Application Number | M005 | ||||
Labeler Name | Blaine Labs Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Drug facts 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 Directions Wash the affected ares with soap and water and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night) or as directed by a physician. 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. For jock itch, use daily for 2 weeks. If condition persists longer, consult a physician. wash hands after each use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive Ingredients Paraffnum Liquidum, Carthamus Tinctorius (Safflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Oreganum Vulgaris (Oregano) Leaf Oil, Tocopheryl acetate, BHT, BHA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylpapaben.
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.Indications Indications Cures most athlete's foot (tinea pedis). Cures most jock itch (tinea cruris) and ring worm (tinea corporis). Relieves itching, cracking, burning, and scaling which accompany these conditions. Prevents most athlete's foot (tinea pedis) with daily use.
Purpose
Information about the drug product’s indications for use.Purpose Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.TINEACIDE TOLNAFTATE TOLNAFTATE TOLNAFTATE MINERAL OIL SAFFLOWER OIL JOJOBA OIL OREGANO LEAF OIL .ALPHA.-TOCOPHEROL ACETATE BUTYLATED HYDROXYTOLUENE BUTYLATED HYDROXYANISOLE PHENOXYETHANOL METHYLPARABEN ETHYLPARABEN PROPYLPARABEN ISOBUTYLPARABEN BUTYLPARABEN
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.Package Label Tineacide Solution Physician Formula Blaine Labs TINEACIDE SOLUTION PHYSICIAN FORMULA Antifungal Treatment Dispensed Only by Physicians NDC: 63347-511-03 15ml (1/2 oz.) Proudly Made in the USA Please Recycle! This package is made from recyclable materials. Exp. / Lot # Patent Pending Blaine Labs Manufactured by Blaine Labs, Inc 11037 Lockport Place Sante Fe Springs, CA 90670 27000-P-BX Rev. 20120921 res Blaine Tineacide Sol1
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 Other Information Store at room temperature.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Questions? Call (800)307-8818, Monday through Friday, 8:00 AM to 5:00 PM (Pacific Time).
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 Stop use and ask 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 When using this product avoid contact with 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 Warnings Do not use on children under 2 years of age unless directed by a physician in or near mouth or eyes for vaginal yeast infections 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