Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameMICONAZOLE NITRATE
Labeler / manufacturerSun Pharmaceutical Industries, Inc.
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC51672-2001
Label effective date2026-08-25
Official product label reference
Miconazole Nitrate — Sun Pharmaceutical Industries, Inc.
This page contains 13 source sections for MICONAZOLE NITRATE, topical route. Label set 7fd4037e-d350-47b7-a7d9-a43b8e366fa0, version 9.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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.
Purpose
Purpose Antifungal
Dosage and administration — label text
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
Warnings
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).
Unclassified section
Drug Facts
Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901
Active ingredient
Active ingredient Miconazole nitrate USP 2%
Do not use
Do not use on children less than 2 years of age unless directed by a doctor
While using this medicine
When using this product avoid contact with eyes
When to stop use and seek help
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.
Child safety
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Storage and handling
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 ingredient
Inactive ingredients apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.