Label: SOOTHE AND COOL TREAT- miconazole nitrate cream
- NDC Code(s): 53329-080-57, 53329-080-58
- Packager: Medline Industries, LP
- 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 August 17, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
-
Uses
- For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- For the treatment of superficial skin infections caused by yeast (candida albicans)
- Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
- Warnings
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Directions
- clean the affected area and dry thoroughly
- apply a thin layer over affected area twice daily or as directed by a physician
- supervise use by children
- 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 four weeks
- for jock itch, use daily for two weeks
- if condition persists longer, consult a doctor
- this product is not effective on scalp or nails
- Other information
- Inactive ingredients
- Manufacturing Information
- Package Label
-
INGREDIENTS AND APPEARANCE
SOOTHE AND COOL TREAT
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-080 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 100 g Inactive Ingredients Ingredient Name Strength CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) 5-HYDROXYMETHYL(METHYLENEOXY)-1-AZA-3,7-DIOXABICYCLO(3,3,0)OCTANE (UNII: 82EKS47IC5) ALLANTOIN (UNII: 344S277G0Z) YELLOW WAX (UNII: 2ZA36H0S2V) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) DIMETHICONE (UNII: 92RU3N3Y1O) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PETROLATUM (UNII: 4T6H12BN9U) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) ZINC OXIDE (UNII: SOI2LOH54Z) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) IMIDUREA (UNII: M629807ATL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-080-57 141 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2007 2 NDC:53329-080-58 56 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2007 04/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M005 01/01/2007 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
