FDA.reportPublic FDA data

Botanimedix TineaRX Antifungal Drying Emulsion

Manufacturer
Cosco International, Inc.
Effective date
2020-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:04:14

Label at a glance#

ProductBotanimedix TineaRX Antifungal Drying Emulsion
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Indications and uses

Cures most athlete's foot, jock itch, and ring worm

Dosage and administration

Apply twice daily for best results.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                          Purpose
Clotrimazole 1%........................Anti-fungal

Uses:

OTC - PURPOSE SECTION

Cures most athlete's foot, jock itch, and ring worm

INDICATIONS & USAGE SECTION

For relief of:

  • Itching, burning, cracking, scaling, and discomfort which accompany these conditions.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply twice daily for best results.

Warnings:

WARNINGS SECTION

For external use only.

When using this product

  • Do not get into eyes.

Stop use and ask a doctor if:

  • Condition worsens.
  • Symptoms last more than 7 days or clear and occur again within a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aluminum Starch Octenylsuccinate, Cannabidiol, Clove Leaf Oil, Dipropylene Glycol, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Myristate, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Ethylhexylglycerin, Polyoxyl 20 Cetostearyl Ether, Tea Tree Oil, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncartoncartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN3
309367clotrimazole 10 MG/ML Topical CreamSCD3
309367clotrimazole 1 % 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
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-5801-02025-01-30C16284748780-12cef2736-914b-d83d-e063-dadaa90ab31fBotanimedix TineaRX Antifungal Drying Emulsion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-5801-0Botanimedix TineaRX Antifungal Drying Emulsion1 in 1 CARTONCREAM13
52261-5801-1Botanimedix TineaRX Antifungal Drying Emulsion0.044 kg in 1 TUBECREAM0.0443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-5801BOTANIMEDIX TINEARX ANTIFUNGAL DRYING EMULSION (CLOTRIMAZOLE) CREAM [COSCO INTERNATIONAL, INC.]3Legacy NDC, 2 package rows20200327_dc80f53b-850e-40e6-9844-2b3b138ae172.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-580152261-5801-1, 52261-5801-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PEPPERMINT OILAV092KU4JHIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2IACT
WATER059QF0KO0RIACT
TEA TREE OILVIF565UC2GIACT
EUCALYPTUS OIL2R04ONI662IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CANNABIDIOL19GBJ60SN5IACT
CLOVE LEAF OILVCA5491KVFIACT
DIPROPYLENE GLYCOLE107L85C40IACT

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
cbb76405-cf2a-49cc-aa80-1495a316afd7dc80f53b-850e-40e6-9844-2b3b138ae1722020-01-30WarningsExact identifier
spl id: cbb76405-cf2a-49cc-aa80-1495a316afd7
spl set id: dc80f53b-850e-40e6-9844-2b3b138ae172

Reported adverse events (FAERS/openFDA)#

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