Label: REMEDY WITH PHYTOPLEX- miconazole nitrate ointment
- NDC Code(s): 53329-171-10
- 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
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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 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 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 ingredients
7-dehydrocholestrol, aphanizomenon flos-aquae (algae) extract, camellia sinensis (green tea) extract, caprylic/capric triglycerides, carboxymethyl cellulose, carthamus tinctorius (safflower) seed oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, olea europaea fruit (olive) oil, petrolatum, phospholipids, tocopherol acetate, water, yeast ferment extract, zea mays (corn) oil
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
REMEDY WITH PHYTOPLEX
miconazole nitrate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-171 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) SAFFLOWER OIL (UNII: 65UEH262IS) DIMETHICONE (UNII: 92RU3N3Y1O) CLOVE (UNII: K48IKT5321) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) OLIVE OIL (UNII: 6UYK2W1W1E) PETROLATUM (UNII: 4T6H12BN9U) CORN OIL (UNII: 8470G57WFM) APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) YEAST (UNII: 3NY3SM6B8U) GLYCERIN (UNII: PDC6A3C0OX) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-171-10 71 g in 1 TUBE; Type 0: Not a Combination Product 04/11/2016 11/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 04/11/2016 11/30/2025 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
