Drug Facts
Active Ingredient
Miconazole Nitrate 2%
Terpenicol Antifungal Solution Liquid
FDA Label NDC 63347-380
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product Terpenicol Antifungal Solution (NDC 63347-380). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, indications & usage, warnings - for external use only, keep out of reach of children., dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose ... Antifungal
Indications & Usage
Uses ■ Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ Relieves discomfort, irritation,
itching, cracking, burning, and scaling skin, which accompany these conditions
Warnings - For External Use Only
Do not use on children under 2 years of age unless directed
by a physician. Do not use in or near the mouth or eyes.
When using this product: avoid contact with eyes.
If eye contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if irritation occurs or if there is
no improvement within 4 weeks for athlete’s foot or ringworm
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison
Control Center (1-800-222-1222) right away.
Dosage & Administration
Directions: ■ Wash the affected area and dry thoroughly
■ Apply a thin layer of the product over the 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 ■ If condition persists longer, consult a doctor ■ This
product is not effective on the scalp or nails. ■ Wash hands before and
after use.
Other Safety Information
Other Information
Store in a dry area at 15°-30°C
(59°-86°F)
Inactive Ingredient
Inactive ingredients
Aminomethylpropanol, Glycerin,
Hydroxypropylcellulose, Isopropyl
Alcohol, Origanum Vulgare (Oregano)
Leaf Oil, Propylene Glycol, Purified
Water, Tocopheryl Acetate, Urea
Blaine Labs® Terpenicol® Antifungal Solution - Product Labeling
----------------------------------
BLAINE LABS®
TERPENICOL®
ANTIFUNGAL SOLUTION
2% MICONAZOLE NITRATE
IN A SOLUTION CONTAINING
UREA & OIL OF OREGANO
1.0 FL OZ (29.6 mL)
MANUFACTURED BY
BLAINE LABS, INC.
11037 LOCKPORT PLACE,
SANTA FE SPRINGS, CA 90670
Box
Bottle
res
* Please review the disclaimer below.
