FDA.reportPublic FDA data

McKesson Antifungal Body Cream

Manufacturer
McKesson | Central Solutions
Effective date
2024-06-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:13:41

Label at a glance#

ProductAntifungal Body
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Purpose

Antifungal

INDICATIONS & USAGE SECTION

Uses

  • for treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • relieves itching,scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
  • for treatment ofsuperficial skin infections caused by yeast (Candida albicans)

WARNINGS SECTION

Warnings

  • For External use only.​

​When using this product

  • Do not get into eyes

Stop use and ask a doctor if

  • irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm, or within 2 weeks for jock itch.

Do not use on

  • children under 2 years of age unless directed by a doctor
  • diaper rash

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clean the affected area and dry thoroughly
  • Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
  • Supervise children in the use of this product

Athlete’s foot

  • Pay special attention to the spaces between toes
  • Wear well-fitting, ventilated shoes and change shoes and socksat least once daily

Athlete’s foot and ringworm

  • Use daily for 4 weeks

Jock itch

  • Use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp or nails.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Isopropyl Palmitate, Glyceryl Stearate, PEG 100 Stearate, Cyclopentasiloxane, Cetearyl Alcohol, Propylene Glycol, Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf Juice, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopherol Acetate (Vitamin E), Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Triethanolamine, DMDM Hydantoin, Iodopropynyl Butylcarbamate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

McKesson Thera Antifungal Body Cream

Helps treat the most common fungal infections including athlete's foot, jock itch and ringworm.

Single Patient Use

Therapy [for the skin]

Net Contents 4 fl oz (118ml)

MFR# 53-AFC4

eacheach

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN7
998483miconazole nitrate 20 MG/ML Topical CreamSCD7
998483miconazole nitrate 2 % Topical CreamSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0206-4Antifungal Body118 mL in 1 TUBECREAM1187

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0206ANTIFUNGAL BODY (MICONAZOLE NITRATE) CREAM [MCKESSON]7Current NDC, Legacy NDC, 1 package rows20240616_4fb9aece-0baa-475e-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68599-0206-4ML - Milliliter68599-020621e81056-e66f-485f-93f3-bca63a0bc61912023-02-06

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-020668599-0206-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
1-BUTENELY001N554LIACT
STEARIC ACID4ELV7Z65APIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALANINEOF5P57N2ZXIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
DIMETHICONE92RU3N3Y1OIACT
ALOEV5VD430YW9IACT
CALCIUM PANTOTHENATE568ET80C3DIACT
NIACINAMIDE25X51I8RD4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LYSINEK3Z4F929H6IACT
ARGININE94ZLA3W45FIACT
THREONINE2ZD004190SIACT
PROLINE9DLQ4CIU6VIACT
GLYCINETE7660XO1CIACT
VALINEHG18B9YRS7IACT
PHENYLALANINE47E5O17Y3RIACT
DMDM HYDANTOINBYR0546TOWIACT
LEUCINEGMW67QNF9CIACT
TYROSINE42HK56048UIACT
TROLAMINE9O3K93S3TKIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
ASPARTIC ACID30KYC7MIAIIACT
SERINE452VLY9402IACT
MALTODEXTRIN7CVR7L4A2DIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
HISTIDINE4QD397987EIACT
GLUTAMIC ACID3KX376GY7LIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PEG-100 STEARATEYD01N1999RIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ETHYLENE GLYCOLFC72KVT52FIACT
CETYL ALCOHOL936JST6JCNIACT

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
Antifungal BodyMICONAZOLE NITRATEMcKesson4fb9aece-0baa-475e-e054-00144ff8d46c2024-06-13WarningsExact identifier
ndc (package): 68599-0206-4
ndc (product): 68599-0206
ndc11 (package): 68599020604
spl id: 1acb3889-ffea-8cd2-e063-6394a90a3ecb
spl set id: 4fb9aece-0baa-475e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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