FDA.reportPublic FDA data

HomeHealth Antifungal Lotion

Manufacturer
Home Health | Pure Source, LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:59:02

Label at a glance#

ProductHomeHealth Antifungal
Active ingredientTOLNAFTATE
Label structure13 sections

Storage and handling

Other information      store in a cool, dry place.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                                           Purpose

Tolnaftate 1.0%..........................................................Antifungal

OTC - PURPOSE SECTION

Uses

- proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm with daily use.  - helps prevent most athlete's foot with daily use.  - for effective relief of itching, burning and cracking.

WARNINGS SECTION

Warnings      For external use only.

INDICATIONS & USAGE SECTION

When using this product avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch.  Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm.

OTC - DO NOT USE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

- 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 physician; - 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. - for jock itch, use daily for 2 weeks. - for athlete's foot and ringworm, use daily for 4 weeks. - if condition persists longer, consult a doctor. - this product is not effective on the scalp or nails.

STORAGE AND HANDLING SECTION

Other information      store in a cool, dry place.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Almond oil, aloe vera gel, calendula oil, castor oil, cetyl alcohol, citricidal (grapefruit seed extract), cocoa butter, diazolidinyl urea, lanolin oil, lavender oil, methylparaben, myrrh tincture, propylene glycol, propylparaben, rosemary oil, stearic acid, tea tree oil, thyme oil, triethanolamine, water.

DESCRIPTION SECTION

Antifungal Lotion provides effective relief of itching, scaling, burning, irritation and discomfort associated with athlete's foot, jock itch and ringworm.  The active ingredient, Tolnaftate, combines with a soothing base of natural botanical extracts to yield a truly unique formula.  You can count on Home Health to deliver the natural heath products your family deserves.  No Mineral Oil, No petroleum, No Artificial Colors, No Artificial Fragrance.  Carefully Manufactured for  HomeHealth, Co. Ronkonxoma, NY 11779 U.S.A. 800-445-7137 www.HomeHealthUS.com 2009 Home Health  B11812 03B

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HomeHealth  Natural Health Begins at Home  Antifungal Lotion  Tolnaftate  Proven Clinicallyl Effective In the Threatment of Most Athlete's Foot, Jock Itch, Ringworm    Net Wt. 4 fl. oz. (118mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antifungal LotionAntifungal Lotion

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283693tolnaftate 1 % Topical LotionPSN6
283693tolnaftate 10 MG/ML Topical LotionSCD6
283693tolnaftate 1 % Topical LotionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76020-100-04HomeHealth Antifungal118 mL in 1 BOTTLELOTION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76020-100HOMEHEALTH ANTIFUNGAL (TOLNAFTATE) LOTION [HOME HEALTH]6Current NDC, Legacy NDC, 1 package rows20231106_895cd24c-3f78-4e2e-bf98-8bb6605798da.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV2
TOLNAFTATEACTIVE MOIETY06KB629TKV2
ALMOND OILINACTIVE INGREDIENT66YXD4DKO92
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW42
GRAPEFRUITINACTIVE INGREDIENTO82C39RR8C2
LANOLININACTIVE INGREDIENT7EV65EAW6H2
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H82
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3932
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G2
THYME OILINACTIVE INGREDIENT2UK410MY6B2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76020-10076020-100-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALMOND OIL66YXD4DKO9IACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CASTOR OILD5340Y2I9GIACT
CETYL ALCOHOL936JST6JCNIACT
GRAPEFRUITO82C39RR8CIACT
COCOA BUTTER512OYT1CRRIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
LANOLIN7EV65EAW6HIACT
LAVENDER OILZBP1YXW0H8IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
ROSEMARY OIL8LGU7VM393IACT
STEARIC ACID4ELV7Z65APIACT
TEA TREE OILVIF565UC2GIACT
THYME OIL2UK410MY6BIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
TOLNAFTATE06KB629TKVACTIB

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 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii+route
4 equally ranked IID candidates
COCOA BUTTERCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii+route
4 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii+route
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
2 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCOA BUTTERCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii+route
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii+route
2 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii+route
4 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii+route
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
HomeHealth AntifungalTOLNAFTATEHome Health895cd24c-3f78-4e2e-bf98-8bb6605798da2023-11-05WarningsExact identifier
ndc (package): 76020-100-04
ndc (product): 76020-100
ndc11 (package): 76020010004
spl id: 09751799-665e-ec58-e063-6394a90aea39
spl set id: 895cd24c-3f78-4e2e-bf98-8bb6605798da

Reported adverse events (FAERS/openFDA)#

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