MICONAZOLE NITRATE powder

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by AvKARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Miconazole Nitrate 2.0%

Purpose

Antifungal

Uses

• for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• for the treatment of most superficial skin infections caused by yeast (candida albicans)
• relieves most 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 by a doctor
• avoid contact with the 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, dicontinue 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 thin layer of powder 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 toes; wear well - fitting, ventilated shoes, and change shoes and socks at least once daily
• for athletes 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.
• do not use if package is damaged

Inactive ingredients

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalcium phosphate, corn starch

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42291-938(NDC:69367-399)
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
ALLANTOIN (UNII: 344S277G0Z)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (White to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42291-938-85	85 g in 1 BOTTLE; Type 0: Not a Combination Product	06/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/05/2024

Labeler - AvKARE (796560394)