Label: MEDLINE- miconazol nitrate ointment
- NDC Code(s): 53329-172-10
- Packager: Medline Industries, LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 29, 2024
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- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- clean the affected area and dry thoroughly
- apply a thin layer of ointment over 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
- Other information
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Inactive ingredient
7-dehydrocholesterol, aphanizomenon flos-aquae (algae) extract, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carboxymethyl cellulose, carthamus tinctorius (safflower) seed oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, olea europaea (olive) fruit oil, petrolatum, phospholipids, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
MEDLINE
miconazol nitrate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-172 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) CLOVE (UNII: K48IKT5321) GLYCERIN (UNII: PDC6A3C0OX) PETROLATUM (UNII: 4T6H12BN9U) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) CORN OIL (UNII: 8470G57WFM) APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X) OLIVE OIL (UNII: 6UYK2W1W1E) WATER (UNII: 059QF0KO0R) SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-172-10 71 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 01/01/2024 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)