Label: MYCOZYL AC- clotrimazole cream
- NDC Code(s): 59088-441-07
- Packager: PureTek Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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.
■ This 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
- Mycozyl AC TM
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INGREDIENTS AND APPEARANCE
MYCOZYL AC
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-441 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 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) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-441-07 85 g in 1 TUBE; Type 0: Not a Combination Product 04/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/06/2021 Labeler - PureTek Corporation (785961046)
