REMEDY ANTIFUNGAL- miconazole nitrate powder 
Medline Industries, Inc.

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 Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control center right away.

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

  • Protect from freezing. Avoid excessive heat.

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, Polymethylsilsesquioxane, 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

NDC 55329-168-79

Medline

Remedy

Antifungal Powder

WITH 2% MICONAZOLE NITRATE

TARGETED TREATMENT

Super absorbent talc-free formula that

helps relieve fungal symptoms of itching,

burning, and irritation.

NON-ALLERGENIC

NON-SENSITIZING

3.0 oz (85 g)

Principal Display Panel - Front Label Antifungal Powder

REMEDY ANTIFUNGAL 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-168
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-168-7985 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/19/201212/31/2017
Labeler - Medline Industries, Inc. (025460908)

Revised: 2/2016
 
Medline Industries, Inc.