FDA.reportPublic FDA data

CIDACIN Antifungal Treatment

Manufacturer
Pedicis Research LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:59:06

Label at a glance#

ProductCIDACIN Antifungal Treatment
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

For the cure of most ringworm (tinea orporis) and athletes foot (tinea pedis) fungal infections.  For the relief of itching; burning; scaling; cracking; redness; soreness; irritation; discomfort that may accompany fungal infections.

Dosage and administration

Clean affected area with soap and water, rinse and dry thoroughly. Apply to affected areas twice daily (morning and night) or as directed by physician. Supervise children in the use of the product.  For athlete's foot: Pay special attention to spaces between the toes. For athlete's foot and ringworm:  Use daily for 4 weeks.  If condition persists longer, consult physician. Formula will dry completely in several mi...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate  1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

For the cure of most ringworm (tinea orporis) and athletes foot (tinea pedis) fungal infections.  For the relief of itching; burning; scaling; cracking; redness; soreness; irritation; discomfort that may accompany fungal infections.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on children unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

avoid eye contact.  If eye contact occurs, rinse thoroughly with water for 10-15 minutes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  •  if irritation occurs
  • no improvement is seen 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 immediately.

Consult a physician

OTC - PREGNANCY OR BREAST FEEDING SECTION

before beginning treatment if pregnant/breast feeding.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean affected area with soap and water, rinse and dry thoroughly.
  • Apply to affected areas twice daily (morning and night) or as directed by physician.
  • Supervise children in the use of the product. 
  • For athlete's foot: Pay special attention to spaces between the toes.
  • For athlete's foot and ringworm:  Use daily for 4 weeks.  If condition persists longer, consult physician.
  • Formula will dry completely in several minutes without residue.
  • Change socks regularly at least once a daily.
  • Wear well-fitted, ventilated shoes.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dimethyl Sulfoxide (DMSO), Green Tea Extract, Ascorbic Acid (Vitamin C), Povidone Iodine, Vitamin E Acetate

Questions:

OTC - QUESTIONS SECTION

call 1-800-748-6539

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROFESSIONAL DISPENSED ONLY BY PHYSICIANS   CIDACIN Antifungal Treatment  PROFESSIONAL  Advanced Antifungal Solution  15mL / 0.5 oz  Distributed by  Pedicis Research LLC Radnor, PA 19087     Patent Pending

CIDACIN Antifungal Treatment 15ml (51151-000-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


CIDACINCIDACIN

CIDACIN BOXCIDACIN BOX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300375CIDACIN 1 % Topical SolutionPSN6
313423tolnaftate 1 % Topical SolutionPSN6
1300375tolnaftate 10 MG/ML Topical Solution [Cidacin]SBD6
313423tolnaftate 10 MG/ML Topical SolutionSCD6
1300375Cidacin 1 % Topical SolutionSY6
1300375Cidacin 10 MG/ML Topical SolutionSY6
313423tolnaftate 1 % Topical SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51151-000-01CIDACIN Antifungal Treatment15 mL in 1 BOTTLESOLUTION156
51151-000-01CIDACIN Antifungal Treatment1 in 1 CARTONSOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51151-000CIDACIN ANTIFUNGAL TREATMENT (TOLNAFTATE) SOLUTION [PEDICIS RESEARCH LLC]6Current NDC, Legacy NDC, 2 package rows20231106_bd53a9e3-65c8-4834-8e23-a2a928b83a66.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV2
TOLNAFTATEACTIVE MOIETY06KB629TKV2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R2
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698H2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
POVIDONE-IODINEINACTIVE INGREDIENT85H0HZU99M2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51151-00051151-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL SULFOXIDEYOW8V9698HIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
POVIDONE-IODINE85H0HZU99MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HSOLUTION / TOPICAL8008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
DIMETHYL SULFOXIDEDIMETHYL SULFOXIDEYOW8V9698HSOLUTION / TOPICAL8008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact 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
CIDACIN Antifungal TreatmentTOLNAFTATEPedicis Research LLCbd53a9e3-65c8-4834-8e23-a2a928b83a662023-11-05WarningsExact identifier
ndc (package): 51151-000-01
ndc (product): 51151-000
ndc11 (package): 51151000001
spl id: 0973a822-e694-feb3-e063-6294a90ab132
spl set id: bd53a9e3-65c8-4834-8e23-a2a928b83a66

Reported adverse events (FAERS/openFDA)#

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