PROCURE ANTIFUNGAL- miconazole nitrate 2% cream

ProCure Antifungal by

Drug Labeling and Warnings

ProCure Antifungal by is a Otc medication manufactured, distributed, or labeled by Twin Med LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Uses:

• Proven clinically effective in the treatment of most Athlete's foot, jock itch and ring worm
• Relieves itching, scaling, cracking and discomfort that can accompany these conditions

Warnings

Warnings

For external use only

Do not use

Do not use on children under 2 years of age unless directed by a doctor

When using this product

When using this product avoid contact with eyes

Stop using and ask a doctor if

Stop using and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete’s foot or ringworm) or 2 weeks (for jock itch)

Keep out of reach of Children

Keep out of reach of Children. In case of accidental ingestion, contact a physician or Poison Control Center right away.

Directions

Directions

• Cleanse affected area and dry thoroughly
• Apply thin layer to affected area twice daily (morning and night) or as directed by a physician
• Supervise children in the use of this product
• For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch use daily for 2 weeks
• For athlete’s foot pay special attention to space between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
• This product is not effective on the scalp or nails

Inactive Ingredients

Inactive Ingredients: Cetostearyl Alcohol, Chlorocresol, Dibasic Sodium Phosphate, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Monobasic Sodium Phosphate Dihydrate, Propylene Glycol, Purified Water, White Petrolatum, Zinc Oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROCURE ANTIFUNGAL 
miconazole nitrate 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55681-047
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
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
CHLOROCRESOL (UNII: 36W53O7109)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
ZINC OXIDE (UNII: SOI2LOH54Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55681-047-04	106 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2025
2	NDC: 55681-047-14	144 in 1 CARTON	10/01/2026
2	NDC: 55681-047-05	5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	12/01/2025

Labeler - Twin Med LLC (009579330)