FDA.reportPublic FDA data

ANTIFUNGAL MEDICATED BODY WASH

Manufacturer
Rida LLC
Effective date
2025-02-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:56:06

Label at a glance#

ProductANTIFUNGAL MEDICATED BODY WASH
Active ingredientTOLNAFTATE
Label structure7 sections

Indications and uses

For treatment of most jock itch ringworm atheletes foot tinea versicolor Relieves itching scaling burning redness cracking associated discomfort

Dosage and administration

Make sure to dry affected area thoroughly. Supervise children in the use of this product. For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor. This product is not effective on the scalp or nails.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1.0%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

For treatment of most

  • jock itch
  • ringworm
  • atheletes foot
  • tinea versicolor

Relieves

  • itching
  • scaling
  • burning
  • redness
  • cracking
  • associated discomfort

WARNINGS SECTION

Warning

For external use only.

When using this product
When using this product avoid contact with the eye

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Make sure to dry affected area thoroughly.
  • Supervise children in the use of this product.
  • For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.

Inactive ingredients

INACTIVE INGREDIENT SECTION

TETRASODIUM GLUTAMATE DIACETATE, EUCALYPTUS OIL, WATER, SODIUM GLUCONATE, SODIUM PALM KERNELATE, GLYCERIN, MELALEUCA ALTERNIFOLIA LEAF, SODIUM CHLORIDE, ACTIVATED CHARCOAL, SODIUM COCOATE, SODIUM PALMATE, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM COCOATE

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2689792tolnaftate 1 % Medicated Liquid SoapPSN3
2689792tolnaftate 10 MG/ML Medicated Liquid SoapSCD3
2689792tolnaftate 1 % Medicated Liquid SoapSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-012-01ANTIFUNGAL MEDICATED BODY WASH56 g in 1 BOTTLE, PLASTICGEL563
83004-012-02ANTIFUNGAL MEDICATED BODY WASH113 g in 1 BOTTLE, PLASTICGEL1133
83004-012-03ANTIFUNGAL MEDICATED BODY WASH226 g in 1 BOTTLE, PLASTICGEL2263
83004-012-04ANTIFUNGAL MEDICATED BODY WASH453 g in 1 PACKAGEGEL4533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83004-012ANTIFUNGAL MEDICATED BODY WASH (TOLNAFTATE) GEL [RIDA LLC]3Current NDC, 4 package rows20250227_e3ebce6f-88ca-4100-ac79-d300f44e4891.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83004-01283004-012-01, 83004-012-02, 83004-012-03, 83004-012-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
EUCALYPTUS OIL2R04ONI662IACT
WATER059QF0KO0RIACT
SODIUM GLUCONATER6Q3791S76IACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
GLYCERINPDC6A3C0OXIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
SODIUM CHLORIDE451W47IQ8XIACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
SODIUM COCOATER1TQH25F4IIACT
SODIUM PALMATES0A6004K3ZIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

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
ANTIFUNGAL MEDICATED BODY WASHTOLNAFTATERida LLCe3ebce6f-88ca-4100-ac79-d300f44e48912025-02-25WarningsExact identifier
ndc (package): 83004-012-04
ndc (package): 83004-012-03
ndc (package): 83004-012-01
ndc (package): 83004-012-02
ndc (product): 83004-012
ndc11 (package): 83004001202
ndc11 (package): 83004001204
ndc11 (package): 83004001201
ndc11 (package): 83004001203
spl id: 2efe0156-5331-f3dc-e063-6394a90ae105
spl set id: e3ebce6f-88ca-4100-ac79-d300f44e4891

Reported adverse events (FAERS/openFDA)#

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