MICONAZOLE NITRATE- antifungal powder

Miconazole nitrate by

Drug Labeling and Warnings

Miconazole nitrate by is a Otc medication manufactured, distributed, or labeled by TWIN MED, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Miconazole nitrate 2%

Purpose

Antifungal

Uses

fFor the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) ■Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet

Warnings

For external use only.

Do not use

: ■On children under 2 years of age unless directed by a doctor ■For diaper rash

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

■Irritation occurs

■There is no improvement within 2 weeks when used for the treatment of jock itch ■There is no improvement within 4 weeks when used for athlete's foot or ringworm

Keep out of reach of children.

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

Directions

• clean the affected area & dry thoroughly
• apply a thin layer of the product 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, & change shoes & socks at least once daily
• for athlete's foot & 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

• Store at room temperature

Inactive ingredients

Colloidal Anhyhdrous Silica, Talcum Powder

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INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
antifungal powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55681-165
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55681-165-03	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/19/2022

Labeler - TWIN MED, LLC (009579330)