TOLNAFTATE ANTIFUNGAL

Manufacturer
Geri-Care Pharmaceuticals, Corp | GCP Laboratories
Effective date
2023-11-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:39

Label at a glance#

ProductTOLNAFTATE ANTIFUNGAL
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

• for effective treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) • for effective relief of itchy, scaly skin between the toes • clears up most athlete’s foot infection and with daily use helps keep it from coming back

Dosage and administration

• shake well before use • clean the affected area and dry thoroughly • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor • supervise children in the use of this product • use daily for 4 weeks. If condition persists longer, consult a doctor. For athlete's foot • pay special attention to the spaces between the toes • wear well-fitting ventilated shoes • ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

PURPOSE

OTC - PURPOSE SECTION

ANTIFUNGAL

USES

INDICATIONS & USAGE SECTION

• for effective treatment of most athlete’s foot (tinea pedis)

and ringworm (tinea corporis)
• for effective relief of itchy, scaly skin between the toes
• clears up most athlete’s foot infection and with daily
use helps keep it from coming back

WARNINGS

WARNINGS SECTION

For external use only
Do not use on children under 2 years of age unless
directed by a doctor.
When using this product avoid contact with the eyes
Stop use and consult a doctor if
• irritation occurs
• there is no improvement within 4 weeks

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control
Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• shake well before use

• clean the affected area and dry thoroughly
• apply a thin layer of the product over affected area
twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product
• use daily for 4 weeks. If condition persists longer,
consult a doctor.

For athlete's foot

• pay special attention to the spaces between the toes
• wear well-fitting ventilated shoes
• change shoes and socks at least once daily
• to prevent athlete’s foot, clean and dry feet thoroughly.
Apply as above once or twice daily.
This product is not effective on the scalp or nails.

Other Information

OTHER SAFETY INFORMATION

• store at room temperature

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

corn starch and talc

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313422tolnaftate 1 % Topical PowderPSN4
313422tolnaftate 0.01 MG/MG Topical PowderSCD4
313422tolnaftate 1 % Topical PowderSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-199-45TOLNAFTATE ANTIFUNGAL45 g in 1 BOTTLE, DISPENSINGPOWDER454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-199TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) POWDER [GERI-CARE PHARMACEUTICALS, CORP]4Current NDC, Legacy NDC, 1 package rows20231109_f9e60430-eec1-4bc2-9522-eb5aa527d90a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-199-45GM - Gram57896-1998484e728-4ce2-4941-82cd-37c07f868cb412017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV1
TOLNAFTATEACTIVE MOIETY06KB629TKV1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
TALCINACTIVE INGREDIENT7SEV7J4R1U1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-19957896-199-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML · Source PDF

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 · 46 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
44 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, EXTENDED RELEASE / ORAL194 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCONCENTRATE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCONCENTRATE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJINSERT / VAGINAL147 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJINSERT / VAGINAL147 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
44 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, EXTENDED RELEASE / ORAL194 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
44 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
TOLNAFTATE ANTIFUNGALTOLNAFTATEGeri-Care Pharmaceuticals, Corpf9e60430-eec1-4bc2-9522-eb5aa527d90a2023-11-08WarningsExact identifier
ndc (package): 57896-199-45
ndc (product): 57896-199
ndc11 (package): 57896019945
spl id: 09a769e6-0aed-0a17-e063-6394a90a85d6
spl set id: f9e60430-eec1-4bc2-9522-eb5aa527d90a

Reported adverse events (FAERS/openFDA)#

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