Label: MICOMITIN ANTIFUNGAL- clotrimazole cream
- NDC Code(s): 59088-642-07
- Packager: PureTek Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 14, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Uses
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Warnings
For external use only.
Do not use
- on children under 2 years of age unless directed by a doctor
- for athlete's foot and ringworm - if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor
- for jock itch - if irritation occurs or if there is no improvement in 2 weeks, discontinue use and consult a doctor
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Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
- 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 doctor.
- his product is not effective on the scalp or nails.
Use under the direction of a medical practitioner
- Other information
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Inactive ingredients
Aqua (Purified Water), Beta-Glucan, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Ethyl Alcohol, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glycine Soja (Soybean) Oil, 1,2-Hexanediol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Panthenol, PEG-100 Stearate, PEG-40 Stearate PEG-8, Polysorbate 60, Propylene Glycol, Sholigopeptide-1, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, DL-Alpha-Tocopheryl Acetate
- Micomitin™ Antifungal Cream
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INGREDIENTS AND APPEARANCE
MICOMITIN ANTIFUNGAL
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-642 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TEA TREE OIL (UNII: VIF565UC2G) NEPIDERMIN (UNII: TZK30RF92W) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SOYBEAN OIL (UNII: 241ATL177A) PANTHENOL (UNII: WV9CM0O67Z) CURDLAN (UNII: 6930DL209R) SHEA BUTTER (UNII: K49155WL9Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) JOJOBA OIL (UNII: 724GKU717M) PEG-40 STEARATE (UNII: ECU18C66Q7) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-642-07 85 g in 1 TUBE; Type 0: Not a Combination Product 04/19/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 04/19/2022 Labeler - PureTek Corporation (785961046)