FDA.reportPublic FDA data

Jock Itch Cream

Manufacturer
TARGET CORPORATION | Sun Pharma Canada Inc.
Effective date
2025-07-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:06:28

Label at a glance#

ProductJock Itch Cream
Active ingredientBUTENAFINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

cures most jock itch relieves itching, burning, crackling, and scaling which accompany 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 apply once a day to affected skin for 2 weeks 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 not visible store between 20° to 25° C (68° to 77° F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Butenafine Hydrochloride 1%

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most jock itch
  • relieves itching, burning, crackling, 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 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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poision 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
  • apply once a day to affected skin for 2 weeks or 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 not visible
  • store between 20° to 25° C (68° to 77° F)

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.

Question?

OTC - QUESTIONS SECTION

1-800-910-6874

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

Target Corporation.,

Minneapolis, MN 55403

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonCompare to active ingredient in Lotrimin Ultra ®Jock Itch*

Jock Itch

Cream

Butenafine Hydrochloride

Cream 1%

  • Prescription strength
  • Relieves itching, burning and chafing
  • Clinically proven to cure most jock itch
  • Contains the drug:

butenafine hydrochloride

up&up TM

NET WT 0.42 oz (12 g)

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
11673-436-01Jock Itch Cream12 g in 1 TUBECREAM123
11673-436-01Jock Itch Cream1 in 1 CARTONCREAM13

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-43611673-436-01

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
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
CETETH-23495CTZ441VIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL DICAPRYLATE581437HWX2IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
BENZYL ALCOHOLLKG8494WBHIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
BUTENAFINE HYDROCHLORIDER8XA2029ZIACTIB

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
A205181-001BUTENAFINE HYDROCHLORIDEBUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16

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 22:38:342026-08A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1684e616aacf4f…
2026-08-18 06:07:402026-07A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-163f01610625f2…
2019-09-15 20:21 UTC2019-09A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205181-001BUTENAFINE HYDROCHLORIDE1%CREAM / TOPICAL2017-11-16f41ea6bd6efb…

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
Jock Itch CreamBUTENAFINE HYDROCHLORIDETARGET CORPORATION1d8a17ae-4e25-f591-e063-6394a90a35dd2025-07-03WarningsExact identifier
ndc (package): 11673-436-01
ndc (product): 11673-436
ndc11 (package): 11673043601
spl id: 3909394c-0658-e681-e063-6394a90a5e04
spl set id: 1d8a17ae-4e25-f591-e063-6394a90a35dd

Reported adverse events (FAERS/openFDA)#

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