MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Rugby Miconazole Nitrate 2%
cca84334-2e2d-4991-9d1e-d5b7c9ffd392
HUMAN OTC DRUG LABEL
Aug 1, 2025
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MICONAZOLE NITRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Packaging
INDICATIONS & USAGE SECTION
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 these conditions.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Miconazole Nitrate 2%
OTC - PURPOSE SECTION
Purpose
Anti-Fungal
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
SPL UNCLASSIFIED SECTION
Other information
Distributed by:
Rugby Laboratories
Indianapolis, IN. 46268
800-616-2471
www.majorpharmaceuticals.com
This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation owner of the registered trademark Micatin.
WARNINGS SECTION
Warnings
For external use only. Do not use if the safety-sealed tube is punctured or damaged.
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).
DOSAGE & ADMINISTRATION SECTION
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 healthcare professional • Supervise children in the use of this product.
For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a doctor • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks at least once daily.
For ringworm: Use daily for 4 weeks. If condition persists, 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.
INACTIVE INGREDIENT SECTION
Inactive ingredientsCarbomer, alcohol, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, mineral oil, mono and di glycerides, polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine, petrolatum.
STORAGE AND HANDLING SECTION
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, tear safety seal off.
Relabeled By: Preferred Pharmaceuticals Inc.