Label: MEDLINE- miconazole nitrate cream
- NDC Code(s): 53329-147-44
- Packager: Medline Industries, LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 28, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- 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
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Inactive ingredients
acrylamide/ammonium acrylate copolymer, aloe barbadensis leaf juice, apricot kernel oil PEG-6 esters, ascorbic acid, ascorbyl palmitate, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil, citrus tangerina (tangerine) peel oil, diazolidinyl urea, ethyl vanillin, glycine, glycine soja (soybean) oil, glycol stearate, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-6 stearate, PEG-8, PEG-32 stearate, polyisobutene, polysorbate 20, propanediol, propylene glycol, propylparaben, pyridoxine HCL, retinyl palmitate, silica, tocopherol, triethanolamine, vanillin, water, zea mays oil
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
MEDLINE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-147 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 1 mL Inactive Ingredients Ingredient Name Strength GLYCINE (UNII: TE7660XO1C) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) GLYCOL STEARATE (UNII: 0324G66D0E) OLIVE OIL (UNII: 6UYK2W1W1E) POLYSORBATE 20 (UNII: 7T1F30V5YH) METHYLPARABEN (UNII: A2I8C7HI9T) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) NIACINAMIDE (UNII: 25X51I8RD4) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) TOCOPHEROL (UNII: R0ZB2556P8) CHOLECALCIFEROL (UNII: 1C6V77QF41) ASCORBYL PALMITATE (UNII: QN83US2B0N) PROPANEDIOL (UNII: 5965N8W85T) APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ) SOYBEAN OIL (UNII: 241ATL177A) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) WATER (UNII: 059QF0KO0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ACETYLCYSTEINE (UNII: WYQ7N0BPYC) PEG-32 STEARATE (UNII: 33GX5WQC0M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROLINE (UNII: 9DLQ4CIU6V) ETHYL VANILLIN (UNII: YC9ST449YJ) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PEG-6 STEARATE (UNII: 8LQC57C6B0) TROLAMINE (UNII: 9O3K93S3TK) TAURINE (UNII: 1EQV5MLY3D) ORANGE OIL (UNII: AKN3KSD11B) MANDARIN OIL (UNII: NJO720F72R) ASCORBIC ACID (UNII: PQ6CK8PD0R) HYDROXYTYROSOL (UNII: QEU0NE4O90) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-147-44 118 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 08/01/2023 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)