FDA.reportPublic FDA data

Pedesil - Aidance Skincare & Topical Solutions, LLC

Manufacturer
Aidance Skincare & Topical Solutions, LLC
Effective date
2012-09-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:33:14

Label at a glance#

ProductPedesil
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

Cures finger and toe area fungal infections. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort and chafing associated with fungal infection.

Dosage and administration

For nail care, wash and dry affected skin. Apply a thin layer of Pedesil around and under entire nail and cuticle twice daily (morning and night) or as directed by a doctor. If you see improvement within 4 weeks of use, you may continue use until satisfactory results are obtained. For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at le...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Cures finger and toe area fungal infections.
  • For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort and chafing associated with fungal infection.

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 eyes.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call poison control or seek medical help.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For nail care, wash and dry affected skin. Apply a thin layer of Pedesil around and under entire nail and cuticle twice daily (morning and night) or as directed by a doctor.
  • If you see improvement within 4 weeks of use, you may continue use until satisfactory results are obtained.
  • For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks.
  • If condition persists longer, consult a doctor. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.

Other Information

OTHER SAFETY INFORMATION


Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

bentonite clay, distilled water, eucalyptus citriodora oil, jojoba seed oil, silver oxide, tea tree oil, zinc oxide.


OTC - QUESTIONS SECTION

Questions? 877-4-AIDANCE

PRINCIPAL DISPLAY PANEL - 28g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN3
1250726Pedesil 1 % Topical CreamPSN3
1250726clotrimazole 10 MG/ML Topical Cream [Pedesil]SBD3
309367clotrimazole 10 MG/ML Topical CreamSCD3
309367clotrimazole 1 % Topical CreamSY3
1250726Pedesil 1 % Topical CreamSY3
1250726Pedesil 10 MG/ML Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24909-303-282020-01-31C16284748780-19d75b9d0-87fd-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24909-303-28Pedesil1 in 1 CARTONCREAM13
24909-303-28Pedesil28 g in 1 BOTTLECREAM283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24909-303PEDESIL (CLOTRIMAZOLE) CREAM [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]3Legacy NDC, 2 package rows20121010_5722424d-25ef-47ce-967b-0c8daee65257.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H653
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H653
BENTONITEINACTIVE INGREDIENTA3N5ZCN45C3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6623
JOJOBA OILINACTIVE INGREDIENT724GKU717M3
SILVER OXIDEINACTIVE INGREDIENT897WUN6G6T3
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G3
WATERINACTIVE INGREDIENT059QF0KO0R3
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z3

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24909-30324909-303-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
BENTONITEA3N5ZCN45CIACT
EUCALYPTUS OIL2R04ONI662IACT
JOJOBA OIL724GKU717MIACT
SILVER OXIDE897WUN6G6TIACT
TEA TREE OILVIF565UC2GIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZIACT

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENTONITEBENTONITEA3N5ZCN45CSUPPOSITORY / VAGINAL288.1 mgExact identifier — unii candidate
11 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSUPPOSITORY / RECTAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CSUSPENSION / ORAL65 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CPOWDER / TOPICAL0.67 mg/mgExact identifier — unii candidate
11 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CSHAMPOO, SUSPENSION / TOPICAL3.25 %w/vExact identifier — unii candidate
11 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CTABLET, COATED / ORAL1.8 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CTABLET / ORAL355 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CCAPSULE / ORALADJ PHExact identifier — unii candidate
11 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CSYSTEM / TRANSDERMAL9.86 mgExact identifier — unii candidate
11 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / INTRAVENOUS3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
BENTONITEBENTONITEA3N5ZCN45CPOWDER, DENTIFRICE / DENTAL0.05 mg/mgExact identifier — unii candidate
11 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CCREAM / TOPICAL4.1 %w/wExact identifier — unii candidate
11 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
8370f4bb-1c1a-42f1-b6a5-7b495bb614ed5722424d-25ef-47ce-967b-0c8daee652572012-09-07WarningsExact identifier
spl id: 8370f4bb-1c1a-42f1-b6a5-7b495bb614ed
spl set id: 5722424d-25ef-47ce-967b-0c8daee65257

Reported adverse events (FAERS/openFDA)#

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