Drug Facts
Active Ingredient
Miconazole Nitrate 2%
Terpenicol Antifungal Cream
FDA Label NDC 63347-470
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 Cream (NDC 63347-470). 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 itching,
cracking, burning and scaling, which accompany
these conditions
Warnings - For External Use Only
When using this product ■ Avoid contact
with eyes: rinse immediately with cool tap water
if contact occurs ■ Do not use for vaginal yeast
infections ■ Do not use on children under 2
years of age unless directed by a doctor
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 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-fiting, ventilated shoes, and
change shoes and socks at least once daily
■ This product is not effective on the scalp or
nails. ■ For athlete's foot and ringworm, use
daily for 4 weeks. ■ If condition persists
longer, consult a doctor
Other Safety Information
Other Information
Store in a dry area at 15°-30°C (59°-86°F)
Inactive Ingredient
Inactive ingredients: Aloe
Barbadensis Leaf Juice, Caprylic Capric
Triglyceride, Cetyl Alcohol, Clotrimazole,
Disodium EDTA, Glyceryl Stearate,
Hydroxyethylcellulose, Lavandula Angustifolia
(Lavender) Flower Extract, Melaleuca Alternifolia
(Tea Tree) Leaf Oil, Methylparaben, PEG-100
Stearate, Polysorbate 60, Propylparaben, Purified
Water, Stearic Acid, Triethanolamine, Urea
Blaine Labs® Terpenicol® Antifungal Cream - Product Label
----------------------------------
BLAINE LABS®
TERPENICOL®
ANTIFUNGAL CREAM
2% MICONAZOLE
NITRATE
1.0 OZ (28 g)
Questions or Comments? 800.307.8818 | Blainelabs.com
M-F, 7:30 am - 4:00 pm (PST) | [email protected]
Manufactured By: Blaine Labs, Inc.
11037 Lockport Place, Santa Fe Springs, CA 90670
res
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