Terbinafine Hydrochloride — v9

Terbinafine Hydrochloride

6 Views

Version

v9

Effective date

September 30, 2025

Original packager

—

Sections captured

15

Identifiers

Document ID
02fc7642-968f-4ddf-a86a-146ed1a40162
Set ID
6016e546-6c02-4af0-888c-c0899865c5f0
Application numbers
ANDA077511
Product NDCs
68788-9814
Package NDCs
68788-9814-1
Original packager NDCs
51672-2080

Names & Manufacturers

Brand names
Terbinafine Hydrochloride
Generic names
TERBINAFINE HYDROCHLORIDE
Manufacturer names
Preferred Pharmaceuticals, Inc
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
TERBINAFINE HYDROCHLORIDE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
012C11ZU6G
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Terbinafine hydrochloride 1%
Do Not Use (1)

Sequence 1

Do not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections
Dosage And Administration (1)

Sequence 1

Directions • adults and children 12 years and older o use the tip of the cap to break the seal and open the tube o wash the affected skin with soap and water and dry completely before applying o for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. ▪ between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. ▪ on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. o for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. o wash hands after each use • children under 12 years: ask a doctor 1 week between the toes 2 weeks on the bottom or sides of the foot Figure 1 Figure 2
Dosage And Administration Table (1)

Sequence 1

adults and children 12 years and olderuse the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingfor athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.wash hands after each usechildren under 12 years: ask a doctor
•ooo▪▪oo•
1 week between the toes 2 weeks on the bottom or sides of the foot
Inactive Ingredient (1)

Sequence 1

Inactive ingredients benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.
Indications And Usage (1)

Sequence 1

Uses • cures most athlete's foot (tinea pedis) • cures most jock itch (tinea cruris) and ringworm (tinea corporis) • relieves itching, burning, cracking and scaling which accompany these conditions
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 30 g Carton Cures Most Athlete's Foot Terbinafine Hydrochloride Cream 1% Antifungal Cream Full Prescription Strength NET WT 1 oz (30 g) Terbinafine Hydrochloride Cream 1%
Purpose (1)

Sequence 1

Purpose Antifungal
Spl Product Data Elements (1)

Sequence 1

Terbinafine Hydrochloride Terbinafine Hydrochloride Terbinafine Hydrochloride Terbinafine benzyl alcohol cetyl alcohol cetyl palmitate isopropyl myristate polysorbate 60 water sodium hydroxide sorbitan monostearate stearyl alcohol
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Relabeled By: Preferred Pharmaceuticals Inc.
Stop Use (1)

Sequence 1

Stop use and ask a doctor if • too much irritation occurs or gets worse. • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
Storage And Handling (1)

Sequence 1

Other information • do not use if seal on tube is broken or is not visible • store at controlled room temperature 20°-25°C (68°-77°F) • see carton or tube crimp for lot number and expiration date
Warnings (1)

Sequence 1

Warnings For external use only Do not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if • too much irritation occurs or gets worse. • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
When Using (1)

Sequence 1

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

OpenFDA raw payload

{'application_number': ['ANDA077511'],
 'brand_name': ['Terbinafine Hydrochloride'],
 'generic_name': ['TERBINAFINE HYDROCHLORIDE'],
 'manufacturer_name': ['Preferred Pharmaceuticals, Inc'],
 'original_packager_product_ndc': ['51672-2080'],
 'package_ndc': ['68788-9814-1'],
 'product_ndc': ['68788-9814'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['02fc7642-968f-4ddf-a86a-146ed1a40162'],
 'spl_set_id': ['6016e546-6c02-4af0-888c-c0899865c5f0'],
 'substance_name': ['TERBINAFINE HYDROCHLORIDE'],
 'unii': ['012C11ZU6G']}