MICONAZOLE NITRATE cream

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• relieves itching, scaling, cracking, burning and discomfort associated with those conditions

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center 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:

• use daily for 4 weeks. If condition persists longer, consult a doctor.
• pay special attention to the spaces between the toes
• wear well-fitting, ventilated shoes
• change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

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 15° - 30°C (59° - 86°F)
• lot number and expiration date: see crimp of tube or see box
• to open: unscrew cap, use pointed end on cap to puncture seal

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

SPL UNCLASSIFIED SECTION

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 10/09 R2
8280719 7805

Repackaged by Preferred Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-0344(NDC: 0603-7805)
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)
PEG-5 OLEATE (UNII: 0240V77G50)
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-0344-2	1 in 1 CARTON	09/02/2014
1		28.4 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 final	part333C	09/02/2014

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc.		791119022	RELABEL(68788-0344)