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| Product NDC Code | 44577-001 | ||||
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| Drug Name | Clarus antifungal |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 103951, 1299059 |
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| Application Number | M005 | ||||
| Labeler Name | Clinical Therapeutic Solutions | ||||
| Packages |
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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: For treatment of athlete's foot and ringworm: To prevent athlete's foot: 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 athlete's foot and ringworm: Use daily for 4 weeks. If condition persists longer, consult a physician. This product is not effective on scalp or nail infections. Clean the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night). Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well-fitting shoes, and change shoes and socks at least once daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Aqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparafin, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Urea.
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: For effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). Relieves: Itching, Scaling, Cracking, Redness, Soreness, Burning, Irritation and prevents the reoccurrence of most athlete's foot with daily use.
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.CLARUS Antifungal TOLNAFTATE WATER ALKYL (C12-15) BENZOATE C13-14 ISOPARAFFIN DIMETHYL SULFONE ETHYLHEXYLGLYCERIN SUNFLOWER OIL LAURETH-7 TEA TREE OIL PHENOXYETHANOL POLYSORBATE 20 UREA 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.CLARUS ANTIFUNGAL CREAM Tolnaftate 1% MEDICAL STRENGTH ANTIFUNGAL CREAM IN A VEHICLE CONTAINING TEA TREE OIL AND UREA CLINICAL THERAPEUTIC SOLUTIONS NET WT. 1.5 oz (45g) PRFOESSIONAL Distributed by Clinical Therapeutic Solutions, PO Box 1257, Wall, NJ 07719 www.CTSRX.com
Product Label Clarus Cream
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 physician.
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 In the case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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 physician if: When using for athlete's foot or ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician. When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a physician.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a healthcare professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store between 20 -25 C (68 -77 F) 0 0 0 0
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. Avoid contact with eyes. Do not use on children under 2 years of age unless directed by a physician. Stop use and ask physician if: When using for athlete's foot or ringworm: if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician. When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a physician. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children In the case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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