MICONAZOLE NITRATE cream

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. 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 use on children less than 2 years of age unless directed by a doctor

When using this product avoid 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

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Cures Most Athlete's Foot

Antifungal Cream

Miconazole Nitrate
Cream USP, 2%
Antifungal Cream

NET WT 1/2 oz (15 g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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 kernel oil (UNII: 54JB35T06A)
benzoic acid (UNII: 8SKN0B0MIM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
glycol stearate (UNII: 0324G66D0E)
mineral oil (UNII: T5L8T28FGP)
polyethylene glycol 300 (UNII: 5655G9Y8AQ)
water (UNII: 059QF0KO0R)
PEG-6 stearate (UNII: 8LQC57C6B0)
PEG-32 stearate (UNII: 33GX5WQC0M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2001-1	1 in 1 CARTON	10/01/1991
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51672-2001-2	1 in 1 CARTON	10/01/1991
2		30 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	10/01/1991

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2001)