Label: REMEDY ANTIFUNGAL- miconazole nitrate powder
- NDC Code(s): 53329-169-79
- 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 December 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
-
Warnings
For external use only
Do not use
- on children under 2 years of age unless directed by a doctor
- avoid contact with eyes
- 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 within 2 weeks, discontinue use and consult a doctor
-
Directions
- Clean the affected area and dry thoroughly
- Apply a layer of power over affected area twice a day (morning and night) or as directed by a doctor
- Supervise children in the use of this product
- For athlete's foot, pay special attention between spaces in toes; wear well fitting, ventilated shoes, and change shoes and socks at least twice 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
-
Inactive ingredients
Aphanizomenon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf
Extract, Caprylic/Capric Triglycerides, 7-Dehydrocholesterol, Dipotassium Glycyrrhizate, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hydrolyzed Soy Protein, Isopropyl Myristate, Methyldihydrojasmonate, Phospholipids, Silica, Sodium Benzoate, Tapioca Starch, Tocopheryl (Vitamin E) Acetate, Vanilla Plantifolia Fruit Extract, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil, Zea Mays (Corn) Starch
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
REMEDY ANTIFUNGAL
miconazole nitrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-169 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 APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055) 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) CLOVE (UNII: K48IKT5321) GLYCERIN (UNII: PDC6A3C0OX) SOY PROTEIN (UNII: R44IWB3RN5) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM BENZOATE (UNII: OJ245FE5EU) STARCH, TAPIOCA (UNII: 24SC3U704I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VANILLA (UNII: Q74T35078H) WATER (UNII: 059QF0KO0R) YEAST (UNII: 3NY3SM6B8U) CORN OIL (UNII: 8470G57WFM) STARCH, CORN (UNII: O8232NY3SJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-169-79 85 g in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M005 11/19/2012 Labeler - Medline Industries, LP (025460908)
