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Silka

Terbinafine Hydrochloride · Cream

Over-the-counter ANDA Official labelling

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Silka Antifungal

Generic name

Terbinafine Hydrochloride

Dosage form

Cream

Route

Topical

Marketing category

ANDA · ANDA

Labeler

Genomma Lab USA, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Terbinafine Hydrochloride	1 g/100g	992528	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Cream

Route of administration

Topical

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Allylamine Antifungal [EPC]	EPC	All 11 members
Allylamine [CS]	CS	All 11 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

077511

Application type

ANDA · Abbreviated New Drug Application

Approval date

July 2, 2007

Sponsor

SUN PHARMA CANADA

Products on application

Submissions recorded

Products approved under application 077511.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
077511-001	TERBINAFINE HYDROCHLORIDE	CREAM		TERBINAFINE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 077511.
Type	No.	Action	Status	Date	Review
Supplement	15	Labeling	Approved	February 28, 2019	Standard
Supplement	5	Manufacturing (CMC)	Approved	October 22, 2014	—
Original application	1		Approved	July 2, 2007	—

Review documents

0 · Original application · March 28, 2012

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250702). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250702

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Antifungal

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years and over use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying. 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. 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 use. children under 12 years: ask a doctor.

Warnings

openFDA Drug Labeling

Warnings For external use only Do not use on nails or scalp in or near the mouth or eyes for vaginal yeast infections When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if too much irritation occurs or gets worse. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

Do not use on nails or scalp in or near the mouth or eyes for vaginal yeast infections

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if too much irritation occurs or gets worse.

Active Ingredient

openFDA Drug Labeling

Active ingredient Terbinafine hydrochloride 1%

Adverse event reports

Source: openFDA FAERS

8,840

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: TERBINAFINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
50066-080-02	50066-080	Genomma Lab USA, Inc.	1 TUBE in 1 CARTON (50066-080-02) / 30 g in 1 TUBE	July 2, 2007
50066-080-03	50066-080	Genomma Lab USA, Inc.	1 TUBE in 1 CARTON (50066-080-03) / 30 g in 1 TUBE	May 21, 2018
50066-080-05	50066-080	Genomma Lab USA, Inc.	1 TUBE in 1 CARTON (50066-080-05) / 15 g in 1 TUBE	December 20, 2018
50066-208-05	50066-208	Genomma Lab USA, Inc.	1 TUBE in 1 CARTON (50066-208-05) / 15 g in 1 TUBE	December 20, 2018
50066-080	50066-080	Genomma Lab USA, Inc.	—	July 2, 2007
50066-208	50066-208	Genomma Lab USA, Inc.	—	July 2, 2007

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.