Terpenicol Antifungal Cream

MICONAZOLE NITRATE CUTANEOUS HUMAN OTC DRUG

Terpenicol Antifungal Cream is an FDA drug label for the active ingredient MICONAZOLE NITRATE manufactured by Blaine Labs Inc. administered by CUTANEOUS. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260701.

Generic name
MICONAZOLE NITRATE
Manufacturer
Blaine Labs Inc.
Product type
HUMAN OTC DRUG
Route
CUTANEOUS
Dosage form
N/A
NDC
63347-470
Application
M005
Label effective
20260701

About this product

Terpenicol Antifungal Cream is an FDA-registered drug product whose active ingredient is MICONAZOLE NITRATE. It is labelled by Blaine Labs Inc. taken by cutaneous and marketed as a human otc drug product. Identifiers on file: NDC 63347-470, application M005, label effective 20260701. It is one of 70 FDA drug label records sharing the active ingredient MICONAZOLE NITRATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing MICONAZOLE NITRATE are most often described in connection with: athlete foot, tinea pedis, corporis relieves, itching cracking. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

DRUG FACTS Active Ingredient Miconazole Nitrate 2%

Indications & Usage

Uses ■ Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ Relieves itching, cracking, burning and scaling, which accompany these conditions

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 ■ T his 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

Warnings

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)

More products with the same ingredient

MICONAZOLE NITRATE

Antifungal Powder

Aldermed Inc. View label

Antifungal Ringworm Treatment Cream

Yunqi Cosmetics (Shenzhen) Co., Ltd View label

Athletes Foot

Premier Brands of America Inc View label

Basic Care Miconazole 7

Amazon.com Services LLC View label

Careone miconazole 7

American Sales Company View label

Claravie

Gentell LLC View label

DG Health Miconazole

Dolgencorp Inc View label

Equaline Miconazole 7

United Natural Foods, Inc. dba UNFI View label

How products containing MICONAZOLE NITRATE compare

FDA lists 70 drug label records with MICONAZOLE NITRATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Safeway 5
— — H E B 3
— — Medline Industries, LP 3
— — Preferred Pharmaceuticals Inc. 3
— — Strategic Sourcing Services LLC 3

Recall and safety notices

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0695-2026 TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01. Blaine Labs Inc Class II Ongoing 20260708

Frequently asked questions

What is Terpenicol Antifungal Cream used for?
Uses ■ Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ Relieves itching, cracking, burning and scaling, which accompany these conditions

Who makes Terpenicol Antifungal Cream?
Blaine Labs Inc. is the labeler of record for Terpenicol Antifungal Cream. 70 FDA label records share the active ingredient MICONAZOLE NITRATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Terpenicol Antifungal Cream come in?
administered by cutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Terpenicol Antifungal Cream prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MICONAZOLE NITRATE?
Yes. 70 FDA drug label records list MICONAZOLE NITRATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Terpenicol Antifungal Cream been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.