Pedesil Maximum Strength - 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 Maximum Strength

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 and 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.

Other Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Bentonite, Eucalyptus Citriodora Oil, Jojoba Seed Oil, Magnesium Oxide, 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 Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
418475	clotrimazole 1 % Topical Ointment	PSN	3
1247979	pedesil MAX 1 % Topical Ointment	PSN	3
1247979	clotrimazole 0.01 MG/MG Topical Ointment [Pedesil]	SBD	3
418475	clotrimazole 0.01 MG/MG Topical Ointment	SCD	3
418475	clotrimazole 1 % Topical Ointment	SY	3
1247979	Pedesil 0.01 MG/MG Topical Ointment	SY	3
1247979	Pedesil MAX 1 % Topical Ointment	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CLOTRIMAZOLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24909-301-28	2020-01-31	C162847	48780-1	9d75b9d0-df00-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24909-301-28	PedesilMaximum Strength	1 in 1 CARTON	OINTMENT	1		3
24909-301-28	PedesilMaximum Strength	28 g in 1 BOTTLE	OINTMENT	28		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24909-301	PEDESIL MAXIMUM STRENGTH (CLOTRIMAZOLE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]	3	Legacy NDC, 2 package rows	20121010_e415c1b8-0cda-4626-b4d0-199ab34d3177.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CLOTRIMAZOLE	ACTIVE INGREDIENT	G07GZ97H65	3
CLOTRIMAZOLE	ACTIVE MOIETY	G07GZ97H65	3
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	3
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	3
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	3
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	3
SILVER OXIDE	INACTIVE INGREDIENT	897WUN6G6T	3
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	3
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	3
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	3

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Pedesil Maximum Strength
Clotrimazole
BENTONITE
EUCALYPTUS OIL
JOJOBA OIL
MAGNESIUM OXIDE
SILVER OXIDE
TEA TREE OIL
WHITE WAX
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
24909-301	24909-301-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CLOTRIMAZOLE	G07GZ97H65	ACTIB
BENTONITE	A3N5ZCN45C	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
JOJOBA OIL	724GKU717M	IACT
MAGNESIUM OXIDE	3A3U0GI71G	IACT
SILVER OXIDE	897WUN6G6T	IACT
TEA TREE OIL	VIF565UC2G	IACT
WHITE WAX	7G1J5DA97F	IACT
ZINC OXIDE	SOI2LOH54Z	IACT

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 · 42 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SUPPOSITORY / RECTAL	375 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, EXTENDED RELEASE / ORAL	14 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT, AUGMENTED / TOPICAL		429 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET / ORAL	5 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	INJECTION, SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SUSPENSION / ORAL	65 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / VAGINAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / TOPICAL		500 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, DELAYED RELEASE / ORAL		78 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	CAPSULE, EXTENDED RELEASE / ORAL		75 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM, AUGMENTED / TOPICAL	10 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	SUPPOSITORY / RECTAL	265 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SHAMPOO, SUSPENSION / TOPICAL	3.25 %w/v		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, DELAYED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	AEROSOL, FOAM / TOPICAL	2 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET / SUBLINGUAL		15 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SUPPOSITORY / VAGINAL	288.1 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, FILM COATED / ORAL		80 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET / ORAL		63 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CAPSULE / ORAL	ADJ PH		Exact identifier — unii candidate 11 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SYSTEM / TRANSDERMAL	9.86 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER / TOPICAL	0.67 mg/mg		Exact identifier — unii candidate 11 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	INJECTION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	POWDER, DENTIFRICE / DENTAL	0.05 mg/mg		Exact identifier — unii candidate 11 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	TABLET / ORAL	355 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	GUM, CHEWING / BUCCAL		173 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	TABLET, COATED / ORAL	1.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SOLUTION / RESPIRATORY (INHALATION)	3.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SOLUTION / INTRAVENOUS	3.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	CREAM / TOPICAL	4.1 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
EUCALYPTUS OIL	EUCALYPTUS OIL	2R04ONI662	SYRUP / ORAL	NA		Exact identifier — unii candidate
MAGNESIUM OXIDE	MAGNESIUM OXIDE	3A3U0GI71G	TABLET, EXTENDED RELEASE / ORAL	25.74 mg		Exact identifier — unii candidate 9 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c47bc18c-aa68-4df2-8eeb-c9daa67f19e6			e415c1b8-0cda-4626-b4d0-199ab34d3177	2012-09-07	Warnings	Exact identifier spl id: c47bc18c-aa68-4df2-8eeb-c9daa67f19e6 spl set id: e415c1b8-0cda-4626-b4d0-199ab34d3177

Reported adverse events (FAERS/openFDA)#

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