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

Pincipal Display Panel

Principal Display and Drug Fact Panel

MICONAZOLE NITRATE
antifungal powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55681-165
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)

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

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

Labeler - TWIN MED, LLC (009579330)

Anti-Fungal Powder Talc