Label: CLARUS ANTIFUNGAL- tolnaftate cream
- NDC Code(s): 44577-470-00
- Packager: Clinical Therapeutic Solutions
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 28, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses:
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Warnings:
For external use only. Avoid contact with the eyes.
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Directions:
For treatment of athlete's foot and ringworm:
- 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.
- To prevent athlete's foot:
- 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.
- Other information:
- Inactive ingredients:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
CLARUS ANTIFUNGAL
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44577-470 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SUNFLOWER OIL (UNII: 3W1JG795YI) LAURETH-7 (UNII: Z95S6G8201) TEA TREE OIL (UNII: VIF565UC2G) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) UREA (UNII: 8W8T17847W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44577-470-00 1 in 1 BOX 03/11/2024 1 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M 03/11/2024 Labeler - Clinical Therapeutic Solutions (078402750)