ANTIFUNGAL- miconazole nitrate powder

Antifungal by

Drug Labeling and Warnings

Antifungal by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC, Davion, Inc. 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), and 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 directed by a doctor.

When using this product avoid contact with the eyes.

Stop and ask a doctor if

• for athlete’s foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks
• for jock itch - if irritation occurs, or if there is no improvement within 2 weeks 

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 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 conditions persist longer, consult a doctor
• this product is not effective on the scalp or nails

Other information

• Store between 20º to 25ºC (68º to 77ºF)
• Protect from freezing. Avoid excessive heat.
• Do not use if package is damaged.

Inactive ingredients

allantoin, chloroxylenol, corn starch, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate.

Questions?

call toll free 1-800-630-8895

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INGREDIENTS AND APPEARANCE

ANTIFUNGAL 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-771
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
STARCH, CORN (UNII: O8232NY3SJ)
IMIDUREA (UNII: M629807ATL)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-771-03	85 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	01/01/2025

Labeler - Advanced Rx LLC (042795108)

Registrant - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
Davion, Inc		079536689	manufacture(80513-771)