MICONAZOLE NITRATE cream

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by H2-Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Miconazole nitrate USP, 2%

Purpose

Antifungal

Uses

• 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 a 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-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 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°-30°C (59°-86°F)
• before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Miconazole Nitrate Cream USP, 2%
Antifungal Cream

NDC: 61269-735-56
*Compare to the active ingredient in
Micatin® Antifungal Cream

Soothes itching, scaling, cracking, and burning | Cures most athlete's foot, jock itch, and ringworm | Clinically proven

Net wt. 1 oz (28 g)

H2 pharma

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61269-735
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
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)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61269-735-14	1 in 1 CARTON	06/29/2021	12/31/2025
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 61269-735-56	1 in 1 CARTON	06/29/2021	12/31/2025
2		28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 61269-735-42	1 in 1 CARTON	06/29/2021	12/31/2025
3		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	06/29/2021	12/31/2025

Labeler - H2-Pharma, LLC (028473634)