FDA.reportPublic FDA data

Tinactin

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:19:37

Label at a glance#

ProductTinactin
Active ingredientTOLNAFTATE
Label structure11 sections

Indications and uses

cures most jock itch (tinea cruris) for effective relief of itching, chafing and burning

Dosage and administration

wash affected area and dry thoroughly apply 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 (tinea cruris)
  • for effective relief of itching, chafing and burning

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

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
  • apply 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

ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum

Questions?

OTC - QUESTIONS SECTION

1-866-360-3266

SPL UNCLASSIFIED SECTION

Distributed by Bayer Healthcare LLC, Whippany, NJ, USA, 07981.

PRINCIPAL DISPLAY PANEL - 15g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tinactin JI 15 g CartonTinactin JI 15 g Carton

TOUCH ACTIN'

Tinactin®
tolnaftate ANTIFUNGAL

CURES MOST JOCK ITCH

ANTIFUNGAL

CREAM

Relieves:

  • itching
  • burning
  • chafing

NET WT
15g (1/2 oz)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209651Tinactin 1 % Topical CreamPSN13
103951tolnaftate 1 % Topical CreamPSN13
209651tolnaftate 10 MG/ML Topical Cream [Tinactin]SBD13
103951tolnaftate 10 MG/ML Topical CreamSCD13
209651Tinactin 1 % Topical CreamSY13
209651Tinactin 10 MG/ML Topical CreamSY13
103951tolnaftate 1 % Topical CreamSY13

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041100409041GTIN-13: 0041100409041
EAN-13: 0041100409041
GTIN-12: 041100409041
UPC-A: 041100409041
GTIN storage (14 digits): 00041100409041		31000359_Tin_JI_15g_Ctn_R - proof report.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0934-2Tinactin15 g in 1 TUBECREAM1513
11523-0934-2Tinactin1 in 1 CARTONCREAM113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0934-2GM - Gram11523-0934072cec90-22ad-4ce7-8c11-d7a8fcdc1c5512017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV2
TOLNAFTATEACTIVE MOIETY06KB629TKV2
CETETH-20INACTIVE INGREDIENTI835H2IHHX2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CHLOROCRESOLINACTIVE INGREDIENT36W53O71092
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SW2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-093411523-0934-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLOROCRESOL36W53O7109IACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
PETROLATUM4T6H12BN9UIACT

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 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / TOPICAL14.2 mgExact identifier — unii+route
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWSYSTEM / TOPICAL14.2 mgExact identifier — unii+route
2 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXCREAM / TOPICAL429 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CHLOROCRESOLCHLOROCRESOL36W53O7109CREAM / TOPICAL5 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXCREAM / TOPICAL429 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CHLOROCRESOLCHLOROCRESOL36W53O7109CREAM / TOPICAL5 mgExact identifier — unii+route+dosage form
2 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
TinactinTOLNAFTATEBayer HealthCare LLC.0a80a5b0-3216-46f6-8801-7066ef59aee42025-12-04WarningsExact identifier
ndc (package): 11523-0934-2
ndc (product): 11523-0934
ndc11 (package): 11523093402
spl id: 4526d753-799d-0ec3-e063-6294a90a270f
spl set id: 0a80a5b0-3216-46f6-8801-7066ef59aee4

Reported adverse events (FAERS/openFDA)#

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