MICONAZOLE NITRATE 2%- miconazole nitrate cream

MICONAZOLE Nitrate 2% by

Drug Labeling and Warnings

MICONAZOLE Nitrate 2% by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Miconazole Nitrate, USP 2%

Purpose

Anti-Fungal

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

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 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

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.

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 20°-25°C (68°-77°F)
• before using any medication, read all label directions. Keep carton, it contains important information.

INACTIVE INGREDIENT

Inactive ingredients cetostearyl alcohol, chlorocresol, disodium EDTA, disodium hydrogen phosphate, dihydrate, light liquid paraffin,
macrogol cetostearyl ether, propylene glycol, purified water, sodium dihydrogen phosphate dihydrate, white soft paraffin

QUESTIONS

Call toll-free 1(877)225-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 2% 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-0071
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
PARAFFINUM LIQUIDUM (UNII: T5L8T28FGP)
CETEARETH-12 (UNII: 7V4MR24V5P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-0071-1	1 in 1 BOX	11/19/2024
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71399-0071-3	1 in 1 BOX	11/19/2024
2		28.4 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 71399-0071-4	1 in 1 BOX	11/19/2024
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	11/19/2024

Labeler - Akron Pharma Inc. (067878881)