FDA.reportPublic FDA data

Lotrimin Ultra

Manufacturer
Bayer Healthcare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:19:41

Label at a glance#

ProductLotrimin Ultra Ringworm
Active ingredientBUTENAFINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

cures most ringworm cures most jock itch cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. relieves itching, burning, cracking, and scaling which accompany these conditions

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 ringworm and jock itch: apply once a day to affected skin for 2 weeks or as directed by a doctor for athlete's foot between the toes : apply to affected skin between and around the toes twice a day for 1 week (morning and night), or onc...

Storage and handling

do not use if seal on tube is broken or not visible store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Butenafine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most ringworm
  • cures most jock itch
  • cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
  • 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 the eyes
  • for vaginal yeast infections

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if too much irritation occurs or irritation 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 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 ringworm and jock itch: apply once a day to affected skin for 2 weeks or as directed by a doctor
  • for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  • 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 not visible
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum

Questions?

SPL UNCLASSIFIED SECTION

Questions? 1-866-360-3266 or visit us a www.lotrimin.com

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298448butenafine HCl 1 % Topical CreamPSN3
1298448butenafine hydrochloride 10 MG/ML Topical CreamSCD3
1298448butenafine HCl 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0158-2Lotrimin UltraRingworm1 in 1 CARTONCREAM13
11523-0158-2Lotrimin UltraRingworm30 g in 1 TUBECREAM303

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-015811523-0158-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
CETETH-23495CTZ441VIACT
PROPYLENE GLYCOL DICAPRYLATE581437HWX2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
BUTENAFINE HYDROCHLORIDER8XA2029ZIACTIB
PETROLATUM4T6H12BN9UIACT

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
N021307-001LOTRIMIN ULTRABUTENAFINE HYDROCHLORIDE1%CREAM / TOPICALRLD, RS2001-12-07

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 22:38:342026-08N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0784e616aacf4f…
2026-08-18 06:07:402026-07N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07f41ea6bd6efb…

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
Lotrimin Ultra RingwormBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.1b438ca7-fd5f-62cb-e063-6294a90ab3a62025-12-04WarningsExact identifier
ndc (package): 11523-0158-2
ndc (product): 11523-0158
ndc11 (package): 11523015802
spl id: 4526df19-7a72-0f19-e063-6394a90a3954
spl set id: 1b438ca7-fd5f-62cb-e063-6294a90ab3a6

Reported adverse events (FAERS/openFDA)#

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