FDA.reportPublic FDA data

AKIN ANTI-FUNGAL

Manufacturer
Southern Sales & Service, Inc.
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:03:00

Label at a glance#

ProductAKIN ANTI-FUNGAL
Active ingredientCLOTRIMAZOLE
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

for the effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • for diaper rash
  • on children under 2 years of age unless directed by doctor
When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
Stop use immediately and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks
If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health rofessional before use.

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 right away. 800.222.1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • apply a thin layer of the product over affeceted area twice daily (morning and night) or as directed by a doctor
  • 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 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

Other information

OTHER SAFETY INFORMATION

  • Store at 15 to 30 °C (59 to 86 °F)
  • do not use if seal on bottle is punctured or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycine soja (soybean) oil,  melaleuca alternifolia (tea tree) leaf oil, metha piperita (perpperminta) oil

AKIN Anti-Fungal Treatment Topical Solution Formula 0.5oz (15 ml) 69822-254-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309370clotrimazole 1 % Topical SolutionPSN5
309370clotrimazole 10 MG/ML Topical SolutionSCD5
309370clotrimazole 1 % Topical SolutionSY5

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-254-052022-07-22C16284748780-19d75b9d0-ec44-f424-e053-dadaa90a57ceAKIN Anti-Fungal Treatment
69822-254-052022-01-28C16284748780-19d75b9d0-ec44-f424-e053-dadaa90a57ceAKIN Anti-Fungal Treatment
69822-254-052020-02-11C16284748780-19d75b9d0-ec44-f424-e053-dadaa90a57ceAKIN Anti-Fungal Treatment
69822-254-052020-01-31C16284748780-19d75b9d0-ec44-f424-e053-dadaa90a57ceAKIN Anti-Fungal Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-254-05AKIN ANTI-FUNGAL15 mL in 1 BOTTLESOLUTION155
69822-254-05AKIN ANTI-FUNGAL1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-254AKIN ANTI-FUNGAL (CLOTRIMAZOLE) SOLUTION [SOUTHERN SALES & SERVICE, INC.]5Legacy NDC, 2 package rows20231201_7836127f-d472-4aac-9443-10f56d735d1f.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-25469822-254-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOYBEAN OIL241ATL177AIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
MENTHA PIPERITA79M2M2UDA9IACT
CLOTRIMAZOLEG07GZ97H65ACTIB

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
0b57d8e4-f9ea-2401-e063-6394a90a31dc7836127f-d472-4aac-9443-10f56d735d1f2023-11-29WarningsExact identifier
spl id: 0b57d8e4-f9ea-2401-e063-6394a90a31dc
spl set id: 7836127f-d472-4aac-9443-10f56d735d1f

Reported adverse events (FAERS/openFDA)#

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