ANTIFUNGAL CREAM- miconazole nitrate cream

Antifungal Cream by

Drug Labeling and Warnings

Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by Encube Ethicals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Miconazole nitrate, USP 2%

PURPOSE

Antifungal

USE(S)

■ proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm

■ for effective relief of itching, scaling, cracking, burning, and discomfort

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 USE AND ASK DOCTOR IF

■ irritation occurs

■ there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

■ clean the affected area and 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 the spaces between the toes; wear well-filling, 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 condition lasts longer, contact a doctor

■ this product is not effective on the scalp or nails

OTHER INFORMATION

■ do not use if foil seal on tube opening is broken or missing

■ to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use

■ store at room temperature 15°C to 30°C (59°F to 86°F)

■ before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENTS

benzoic acid, butylatyIated; hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7stearate, purified water

QUESTIONS OR COMMENTS?

Call 1-833-285-4151

PRINCIPAL DISPLAY PANEL

Antifungal Cream
Miconazole Nitrate Cream, USP 2%

NET WT. 1.5 OZ (42.5 g)

INGREDIENTS AND APPEARANCE

ANTIFUNGAL CREAM 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21922-095
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
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
MINERAL OIL (UNII: T5L8T28FGP)
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21922-095-06	1 in 1 CARTON	03/06/2025
1		42.5 g in 1 TUBE; 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	03/06/2025

Labeler - Encube Ethicals Private Limited (915834105)

Establishment
Name	Address	ID/FEI	Business Operations
Encube Ethicals Private Limited		725076298	ANALYSIS(21922-095) , LABEL(21922-095) , MANUFACTURE(21922-095) , PACK(21922-095)