REMEDY ANTIFUNGAL- miconazole nitrate powder

Remedy Antifungal by

Drug Labeling and Warnings

Remedy Antifungal by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, 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 powder

Product 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	part333C	11/19/2012

Labeler - Medline Industries, Inc. (025460908)