MICONAZOLE NITRATE cream

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Miconazole nitrate USP 2%

Purpose

Antifungal

Uses

• effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
• for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Warnings

For external use only

Do not useon children less than 2 years of age unless directed by a doctor

When using this productavoid contact with eyes

Stop use and ask a doctor if

• irritation occurs
• condition persists
• there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

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

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 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
• not effective on the scalp or nails

Other information

• To open: unscrew cap, use pointed end on cap to puncture seal
• store at 20° - 25°C (68° - 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Questions?

Call 1-866-923-4914

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Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

HOW SUPPLIED

Product: 50090-1071

NDC: 50090-1071-0 15 g in a TUBE / 1 in a CARTON

Miconazole Nitrate

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-1071(NDC:51672-2001)
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
APRICOT SEED OIL (UNII: 54JB35T06A)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCOL STEARATE (UNII: 0324G66D0E)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-6 (UNII: 5655G9Y8AQ)
WATER (UNII: 059QF0KO0R)
PEG-6 MONOSTEARATE (UNII: 8LQC57C6B0)
PEG-32 MONOSTEARATE (UNII: 33GX5WQC0M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-1071-0	1 in 1 CARTON	11/28/2014
1		15 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	10/01/1991

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-1071)