FDA.reportPublic FDA data

MacerRx Web Gel

Manufacturer
Clinical Therapeutic Solutions
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:59:07

Label at a glance#

ProductMacerRx Web
Active ingredientMICONAZOLE NITRATE
Label structure6 sections

Indications and uses

Proven clinically to cure most: athlete’s foot (tinea pedis) ringworm (tinea corporis) Effectively soothese and relieves: itching burning cracking Helps prevent most athlete’s foot from coming back with daily use For the treatment of superficial skin infections caused by yeast (Candida albicans, intertrigo) and erythrasma

Dosage and administration

clean the affected area and dry thoroughly apply a thin layer over the affected area twice daily (morning and night) supervise children in the use of this product for athlete’s foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks. If condition lasts longer, ask a doctor to prevent athlete’s foot, apply to t...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

-Miconazole Nitrate 2.00%

OTC - PURPOSE SECTION

Antifungal

Uses:

INDICATIONS & USAGE SECTION

Proven clinically to cure most:

  • athlete’s foot (tinea pedis)
  • ringworm (tinea corporis) Effectively soothese and relieves:
  • itching
  • burning
  • cracking
  • Helps prevent most athlete’s foot from coming back with daily use
  • For the treatment of superficial skin infections caused by yeast (Candida albicans, intertrigo) and erythrasma

Warnings:

WARNINGS SECTION

  • For external use only

When using this product:

OTC - WHEN USING SECTION

  • Avoid contact with eyes

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Irritation occurs
  • There is no improvement within 4 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, contact physician or poison control center immediately.

Store at room

STORAGE AND HANDLING SECTION

temperature 68-77ºF (20-25º C)

Directions:

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area and dry thoroughly
  • apply a thin layer over the affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • use daily for 4 weeks. If condition lasts longer, ask a doctor
  • to prevent athlete’s foot, apply to the feet once or twice daily
  • this product is not effective on the scalp or nails

Other Ingredients:

INACTIVE INGREDIENT SECTION

Acetic Acid, Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, Hamamelis Virginiana (Witch Hazel) Distillate, Hydroxyethylcellulose, Melaleuca Alternifolia (Tea Tree Oil), Methylsulfonylmethane (MSM), Phenoxyethanol, SD-Alcohol, Triethanolamine

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label00Label00

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1425866MacerRx 2 % Topical CreamPSN5
998483miconazole nitrate 2 % Topical CreamPSN5
1425866miconazole nitrate 20 MG/ML Topical Cream [MacerRx]SBD5
998483miconazole nitrate 20 MG/ML Topical CreamSCD5
1425866MacerRx 2 % Topical CreamSY5
1425866MacerRx 20 MG/ML Topical CreamSY5
998483miconazole nitrate 2 % Topical CreamSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44577-205-56MacerRx Web1 in 1 CARTONCREAM15
44577-205-56MacerRx Web56 g in 1 TUBECREAM565

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-205MACERRX WEB (MICONAZOLE NITRATE) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231106_c9327f41-10f1-41f3-855b-838c701d6767.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1K1
MICONAZOLEACTIVE MOIETY7NNO0D7S5M1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063P1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FT1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44577-20544577-205-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETIC ACIDQ40Q9N063PIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WITCH HAZEL101I4J0U34IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
TEA TREE OILVIF565UC2GIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

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 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ACETIC ACIDACETIC ACIDQ40Q9N063PCREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL36 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL36 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PCREAM / TOPICALNAExact identifier — unii+route+dosage form
2 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
MacerRx WebMICONAZOLE NITRATEClinical Therapeutic Solutionsc9327f41-10f1-41f3-855b-838c701d67672023-11-05WarningsExact identifier
ndc (package): 44577-205-56
ndc (product): 44577-205
ndc11 (package): 44577020556
spl id: 0973aae6-55b5-5f1a-e063-6394a90a9848
spl set id: c9327f41-10f1-41f3-855b-838c701d6767

Reported adverse events (FAERS/openFDA)#

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