Dr. Scholl's Terbinafine Hydrochloride Cream 1%

Manufacturer
Scholl's Wellness Company LLC | Sun Pharma Canada Inc.
Effective date
2026-04-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:52:32

Label at a glance#

ProductTerbinafine Hydrochloride
Active ingredientTERBINAFINE HYDROCHLORIDE
Label structure11 sections

Indications and 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

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 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 ...

Storage and handling

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR 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 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

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
    • for athlete's footwear 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 weekor as directed by a doctor
      • on the bottom or sides of the foot:apply twice a day (morning and night) for 2 weeksor as directed by a doctor
    • for jock itch and ringworm: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
DirectionsDirections1 week between the toes DirectionsDirections2 weeks on the bottom or sides of the foot

Other information

STORAGE AND HANDLING SECTION

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR 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 1-866-360-3226

SPL UNCLASSIFIED SECTION

Dist. by: Scholl’s Wellness Company LLC
Parsippany, NJ 07054

Made in Canada.

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130888853004846GTIN-13: 0888853004846
EAN-13: 0888853004846
GTIN-12: 888853004846
UPC-A: 888853004846
GTIN storage (14 digits): 00888853004846
Dr. Scholls Terbinafine Carton Rev.jpg

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
73469-7215-2Terbinafine Hydrochloride1 in 1 CARTONCREAM14
73469-7215-2Terbinafine Hydrochloride30 g in 1 TUBECREAM304

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73469-721573469-7215-2

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-03-19monthly-update2026-06-03 17:58:54

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
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEScholl's Wellness Company LLC31f59302-eaee-211b-e063-6294a90a08b02026-04-03WarningsExact identifier
ndc (package): 73469-7215-2
ndc (product): 73469-7215
ndc11 (package): 73469721502
spl id: 4e91f275-e628-27c4-e063-6294a90ad0c4
spl set id: 31f59302-eaee-211b-e063-6294a90a08b0

Reported adverse events (FAERS/openFDA)#

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