Lotrimin Ultra

Manufacturer: Bayer Healthcare LLC.
Effective date: 2025-12-04
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:20:05

Label at a glance#

ProductLotrimin Ultra

Active ingredientBUTENAFINE HYDROCHLORIDE

Label structure14 sections

Indications and uses

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 this condition

Dosage and administration

adults and children 12 years and older: wash the affected skin with soap and water and dry completely before applying to open the applicator, twist the base to the ON position. Squeeze tube to dispense cream. 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, ve...

Storage and handling

store between 20° to 25°C (68° to 77°F)

Contacts and useful links#

PhoneLabel contact1-866-360-3266

Websitewww.lotrimin.com

www.lotrimin.com

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 athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
relieves itching, burning, cracking, and scaling which accompany this condition

Warnings

WARNINGS SECTION

For external use only

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:
- wash the affected skin with soap and water and dry completely before applying
- to open the applicator, twist the base to the ON position. Squeeze tube to dispense cream.
- 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.
- wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position
- wash hands after each use
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

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?

OTC - QUESTIONS SECTION

1-866-360-3266 or visit us at www.lotrimin.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOTRIMIN ULTRA ®

BUTENAFINE HYDROCHLORIDE CREAM 1% ANTIFUNGAL

NET WT 20g (0.70 OZ)

Lotrimin Ultra

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1298448	butenafine HCl 1 % Topical Cream	PSN	7
1298448	butenafine hydrochloride 10 MG/ML Topical Cream	SCD	7
1298448	butenafine HCl 1 % Topical Cream	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BUTENAFINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11523-0082-1	Lotrimin Ultra	20 g in 1 TUBE, WITH APPLICATOR	CREAM	20		7
11523-0082-1	Lotrimin Ultra	1 in 1 CARTON	CREAM	1		7

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Lotrimin Ultra
Butenafine hydrochloride
STEARIC ACID
TROLAMINE
GLYCERIN
WHITE PETROLATUM
BENZYL ALCOHOL
BUTENAFINE
CETYL ALCOHOL
WATER
SODIUM BENZOATE
CETETH-23
GLYCERYL MONOSTEARATE
PROPYLENE GLYCOL DICAPRYLATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-0082	11523-0082-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
GLYCERIN	PDC6A3C0OX	IACT
WHITE PETROLATUM	B6E5W8RQJ4	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
BUTENAFINE HYDROCHLORIDE	R8XA2029ZI	ACTIB
CETYL ALCOHOL	936JST6JCN	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
CETETH-23	495CTZ441V	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PROPYLENE GLYCOL DICAPRYLATE	581437HWX2	IACT

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021307-001	LOTRIMIN ULTRA	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL		RLD, RS	2001-12-07

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lotrimin Ultra	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	d11dfdf6-9b36-03bc-e053-2995a90a0bc3	2025-12-04	Warnings	Exact identifier ndc (package): 11523-0082-1 ndc (product): 11523-0082 ndc11 (package): 11523008201 spl id: 4526ca36-993f-b574-e063-6294a90a8fba spl set id: d11dfdf6-9b36-03bc-e053-2995a90a0bc3

Reported adverse events (FAERS/openFDA)#

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