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| Product NDC Code | 76020-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Homehealth antifungal |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 283693 | ||||
| Application Number | M005 | ||||
| Labeler Name | Home Health | ||||
| 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 Purpose Tolnaftate 1.0%..........................................................Antifungal
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Antifungal Lotion provides effective relief of itching, scaling, burning, irritation and discomfort associated with athlete's foot, jock itch and ringworm. The active ingredient, Tolnaftate, combines with a soothing base of natural botanical extracts to yield a truly unique formula. You can count on Home Health to deliver the natural heath products your family deserves. No Mineral Oil, No petroleum, No Artificial Colors, No Artificial Fragrance. Carefully Manufactured for HomeHealth, Co. Ronkonxoma, NY 11779 U.S.A. 800-445-7137 www.HomeHealthUS.com 2009 Home Health B11812 03B
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 the affected area and dry thoroughly; - apply a thin layer of the product 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 jock itch, use daily for 2 weeks. - 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: Almond oil, aloe vera gel, calendula oil, castor oil, cetyl alcohol, citricidal (grapefruit seed extract), cocoa butter, diazolidinyl urea, lanolin oil, lavender oil, methylparaben, myrrh tincture, propylene glycol, propylparaben, rosemary oil, stearic acid, tea tree oil, thyme oil, triethanolamine, 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.When using this product avoid contact with eyes.
Purpose
Information about the drug product’s indications for use.Uses - proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm with daily use. - helps prevent most athlete's foot with daily use. - for effective relief of itching, burning and cracking.
Spl product data elements
Usually a list of ingredients in a drug product.HomeHealth Antifungal TOLNAFTATE ALMOND OIL ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER CASTOR OIL CETYL ALCOHOL GRAPEFRUIT COCOA BUTTER DIAZOLIDINYL UREA LANOLIN LAVENDER OIL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN ROSEMARY OIL STEARIC ACID TEA TREE OIL THYME OIL TROLAMINE 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.HomeHealth Natural Health Begins at Home Antifungal Lotion Tolnaftate Proven Clinicallyl Effective In the Threatment of Most Athlete's Foot, Jock Itch, Ringworm Net Wt. 4 fl. oz. (118mL)
Antifungal Lotion
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 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 irritation occurs or if there is no improvement within 2 weeks for jock itch. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm.
Storage and handling
Information about safe storage and handling of the drug product.Other information store in a cool, dry place.
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