FDA.reportPublic FDA data

Antifungal Athletes Foot Cream

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd.
Effective date
2020-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:39

Label at a glance#

ProductLucky SuperSoft Athletes Foot
Active ingredientCLOTRIMAZOLE
Label structure12 sections

Indications and uses

■ cures most athlete's foot, jock itch, and ringworm ■ relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Dosage and administration

■ wash affected area and dry thoroughly ■ apply a  thin layer over affected area twice daily  (morning and night) ■ 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 a day ■ for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks ■ if co...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

■ cures most athlete's foot, jock itch, and ringworm ■ relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

children under 2 years of age unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

■ irritation occurs ■ there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (jock itch)

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ wash affected area and dry thoroughly ■ apply a  thin layer over affected area twice daily  (morning and night) ■ 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 a day ■ for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks ■ if conditions persist longer, ask a doctor ■ this product is not effective on the scalp or nails.

Other Information

SPL UNCLASSIFIED SECTION

■  store between 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetearyl alcohol, cetyl esters wax, octyldodecanol, polysorbate 60, sorbitan monostearate, stearyl alcohol, water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN1
309367clotrimazole 10 MG/ML Topical CreamSCD1
309367clotrimazole 1 % Topical CreamSY1

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
47046-173-012022-01-28C16284748780-1d6a99b39-e771-a426-e053-dadaa90af4c2Antifungal Athletes Foot Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-173-01Lucky SuperSoftAthletes Foot42.5 g in 1 TUBECREAM42.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-173LUCKY SUPERSOFT ATHLETES FOOT (CLOTRIMAZOLE) CREAM [ANICARE PHARMACEUTICALS PVT. LTD.]1Legacy NDC, 1 package rows20201221_b6e18374-9a0f-804d-e053-2995a90a07c3.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47046-17347046-173-01

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
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ESTERS WAXD072FFP9GUIACT
OCTYLDODECANOL461N1O614YIACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
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
b6e18380-dc95-3e9a-e053-2995a90ab9bfb6e18374-9a0f-804d-e053-2995a90a07c32020-12-20WarningsExact identifier
spl id: b6e18380-dc95-3e9a-e053-2995a90ab9bf
spl set id: b6e18374-9a0f-804d-e053-2995a90a07c3

Reported adverse events (FAERS/openFDA)#

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