FDA.reportPublic FDA data

CVS

Manufacturer
CVS Pharmacy | Sun Pharma Canada Inc.
Effective date
2025-11-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:17:59

Label at a glance#

ProductCVS
Active ingredientTERBINAFINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and older 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 jock itch 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°-25°C (68°-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 accompanies 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 the eyes
  • for vaginal yeast infections

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • too much irritation occurs or gets worse.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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 older
    • 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 jock itchapply 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°-25°C (68°-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 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket
RI 02895

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSHealth ™

Compare to the active ingredient in Lamisil AT ®*
NDC 59779-523-01

Full Prescription Strength
Jock Itch Cream
TERBINAFINE HYDROCHLORIDE CREAM 1%
Antifungal cream

NET WT .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
992528terbinafine HCl 1 % Topical CreamPSN4
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD4
992528terbinafine hydrochloride 1 % Topical CreamSY4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-523-012025-11-25C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012025-07-29C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012024-04-30C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012023-01-30C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012021-06-18C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS
59779-523-012020-01-31C16284748780-19d75b9d0-c9f1-f424-e053-dadaa90a57ceCVS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-523-01CVS1 in 1 CARTONCREAM14
59779-523-01CVS15 g in 1 TUBECREAM154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-523-01GM - Gram59779-523c6e9ed78-6829-46a3-b492-75485da0cb5122018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6G1
TerbinafineACTIVE MOIETYG7RIW8S0XP1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBH1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08X1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJS1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4M1
sodium hydroxideINACTIVE INGREDIENT55X04QC32I1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58X1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1Y1
waterINACTIVE INGREDIENT059QF0KO0R1

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
59779-52359779-523-01

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
isopropyl myristateISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cetyl palmitateCETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
stearyl alcoholSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
CVSTERBINAFINE HYDROCHLORIDECVS Pharmacy17684ba2-3c2c-4259-84fa-3833f19e5a4d2025-11-25WarningsExact identifier
ndc (package): 59779-523-01
ndc (product): 59779-523
ndc11 (package): 59779052301
spl id: 446e5c7a-48c9-cef4-e063-6294a90a6d32
spl set id: 17684ba2-3c2c-4259-84fa-3833f19e5a4d

Reported adverse events (FAERS/openFDA)#

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