Tinactin

Manufacturer
Bayer HealthCare LLC.
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:19:52

Label at a glance#

ProductTinactin Super Absorbent
Active ingredientTOLNAFTATE
Label structure12 sections

Indications and uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching, burning and cracking

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 for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once or twi...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning and cracking

Warnings

WARNINGS SECTION

For external use only

Avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age except under the advice and supervision of a doctor.

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
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

benzethonium chloride, corn starch, kaolin, sodium bicarbonate

OTC - QUESTIONS SECTION

Questions? 1-866-360-3266

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.8 oz. Can3.8 oz. Can

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV2
TOLNAFTATEACTIVE MOIETY06KB629TKV2
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D057442
KAOLININACTIVE INGREDIENT24H4NWX5CO2
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6T2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO2

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
11523-436211523-4362-1

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 1 · 55 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, FILM COATED / ORAL86 mgExact identifier — unii candidate
34 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, SOLUTION / INTRAVENOUS52 mgExact identifier — unii candidate
34 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TSUSPENSION / ORAL920 mgExact identifier — unii candidate
2 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COTABLET, DELAYED RELEASE / ORAL18.5 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS3059 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVENOUS812 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOPOWDER, FOR SOLUTION / ORAL1250 mg/100mlExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii candidate
34 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
34 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE, EXTENDED RELEASE / ORAL21 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / ORAL360 mgExact identifier — unii candidate
34 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE, COATED PELLETS / ORAL234 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / SUBLINGUAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COTABLET, EXTENDED RELEASE / ORAL66 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAVENOUS1 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
34 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COTABLET, COATED / ORAL52.44 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS160 mgExact identifier — unii candidate
34 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TCAPSULE / ORAL107 mgExact identifier — unii candidate
2 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRATHECAL0.05 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOCAPSULE, DELAYED RELEASE PELLETS / ORAL4 mgExact identifier — unii candidate
34 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COSYSTEM / TOPICAL420 mgExact identifier — unii candidate
13 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAMUSCULAR175 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOCAPSULE / ORAL320 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EXTENDED RELEASE / ORAL81 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION/ DROPS / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE, DELAYED RELEASE PELLETS / ORAL234 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVITREAL0.18 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COTABLET / ORAL150 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COSYRUP / ORAL10 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COPOWDER / TOPICAL10056 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3219 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
34 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
e5bed8a1-c4a4-65b8-e053-2a95a90a9b261eb6254d-8ea1-2c2f-e054-00144ff8d46c2022-08-08WarningsExact identifier
spl set id: 1eb6254d-8ea1-2c2f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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