Tinactin

Manufacturer
Bayer HealthCare LLC
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:40:58

Label at a glance#

ProductTinactin
Active ingredientTOLNAFTATE
Label structure10 sections

Indications and uses

cures most jock itch for effective relief of itching, chafing and burning

Dosage and administration

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product use daily for 2 weeks; if condition persists longer, ask a doctor this product is not effective on the scalp or nails

Storage and handling

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

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most jock itch
  • for effective relief of itching, chafing and burning

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

Flammable: Do not use while smoking or near heat or flame

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 2 weeks

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

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 2 weeks; if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, isobutane, PPG-12-buteth-16, SD alcohol 40-B (11% v/v), talc

Questions?

OTC - QUESTIONS SECTION

1-866-360-3266

PRINCIPAL DISPLAY PANEL - 133g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11523-0072-5

TOUGH ACTIN' ®

Tinactin®

ANTIFUNGAL

tolnaftate

Cures most

jock itch

POWDER SPRAY

goes on dry

Relieves itching,

burning & chafing

NET WT 133g (4.6 oz)

133 g Label133 g Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
705936Tinactin 1 % Powder SprayPSN9
705934tolnaftate 1 % Powder SprayPSN9
705936tolnaftate 0.01 MG/MG Powder Spray [Tinactin]SBD9
705934tolnaftate 0.01 MG/MG Powder SpraySCD9
705936Tinactin 0.01 MG/MG Powder SpraySY9
705936Tinactin 1 % Powder SpraySY9
705934tolnaftate 1 % Powder SpraySY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-0072-52025-07-29C16284748780-13b156c62-2a8f-fb37-e063-e6dba90a4e07Tinactin ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0072-5Tinactin133 g in 1 CANAEROSOL, POWDER1339

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0072TINACTIN (TOLNAFTATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC]9Legacy NDC, 1 package rows20241208_89a888a2-7b1a-4e11-8504-5efe3faab3c8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKV1
TolnaftateACTIVE MOIETY06KB629TKV1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171K1
isobutaneINACTIVE INGREDIENTBXR49TP6111
PPG-12-buteth-16INACTIVE INGREDIENT58CG7042J11
talcINACTIVE INGREDIENT7SEV7J4R1U1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-007211523-0072-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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 2 · 71 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
isobutaneISOBUTANEBXR49TP611AEROSOL, SPRAY / TOPICAL4484 mgExact identifier — unii candidate
4 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UPOWDER, FOR SUSPENSION / ORAL735 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, LIQUID FILLED / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, DELAYED RELEASE / ORAL420 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
isobutaneISOBUTANEBXR49TP611AEROSOL, FOAM / RECTAL142 mgExact identifier — unii candidate
4 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSHAMPOO / TOPICAL0.1 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL, METERED / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 equally ranked IID candidates
isobutaneISOBUTANEBXR49TP611AEROSOL, FOAM / TOPICAL18 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSWAB / TOPICAL0.5 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KLOTION / TOPICAL1000 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION, CONCENTRATE / ORAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UCAPSULE, COATED / ORAL87 mgExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / SUBLINGUAL0.13 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / ORAL14 mgExact identifier — unii candidate
32 equally ranked IID candidates
talcTALC7SEV7J4R1UDROPS / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
isobutaneISOBUTANEBXR49TP611AEROSOL / TOPICAL4484 mgExact identifier — unii candidate
4 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KOINTMENT / TOPICAL57 mgExact identifier — unii candidate
32 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates

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
289dd39a-a214-40f3-e063-6394a90adcf189a888a2-7b1a-4e11-8504-5efe3faab3c82024-12-06WarningsExact identifier
spl id: 289dd39a-a214-40f3-e063-6394a90adcf1
spl set id: 89a888a2-7b1a-4e11-8504-5efe3faab3c8

Reported adverse events (FAERS/openFDA)#

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