FDA.reportPublic FDA data

Silka

Manufacturer
Genomma Lab USA, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:20

Label at a glance#

ProductSilka Jock Itch
Active ingredientTERBINAFINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

cures most jock itch (tinea cruris) relieves itching, burning, cracking and scaling which accompany this condition

Dosage and administration

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 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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Terbinafine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most jock itch (tinea cruris)
  • relieves itching, burning, cracking and scaling which accompany this condition

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor iftoo much irritation occurs or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
    • apply once a day (morning ornight) for 1 weekor as directed by a doctor
    • wash hands after each use
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

call 1 877 99 GENOM (43666)

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc., Houston, TX, 77027

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SILKA ®
Terbinafine Hydrochloride Cream 1%
ANTIFUNGAL CREAM

FULL PRESCRIPTION
STRENGTH

JOCK ITCH

CURES MOST JOCK ITCH
NET WT 0.5 oz (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1739221SILKA 1 % Topical CreamPSN2
992528terbinafine HCl 1 % Topical CreamPSN2
1739221terbinafine hydrochloride 10 MG/ML Topical Cream [Silka Cream]SBD2
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD2
1739221Silka 1 % Topical CreamSY2
1739221Silka Cream 10 MG/ML Topical CreamSY2
992528terbinafine hydrochloride 1 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TERBINAFINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-208-05Silka Jock Itch15 g in 1 TUBECREAM152
50066-208-05Silka Jock Itch1 in 1 CARTONCREAM12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-20850066-208-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CETYL ALCOHOL936JST6JCNIACT
CETYL PALMITATE5ZA2S6B08XIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TERBINAFINE HYDROCHLORIDE012C11ZU6GACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077511-001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0284e616aacf4f…
2026-08-18 06:07:402026-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silka Jock ItchTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.326d8586-042f-44f8-8530-e46b7b777bc32025-07-02WarningsExact identifier
ndc (package): 50066-208-05
ndc (product): 50066-208
ndc11 (package): 50066020805
spl id: 38f65202-ed21-e74d-e063-6294a90a2882
spl set id: 326d8586-042f-44f8-8530-e46b7b777bc3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.