FDA.reportPublic FDA data

Relispray Antifungal Spray Powder

Manufacturer
Midas-Care Pharmaceuticals Pvt. Ltd.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:44:48

Label at a glance#

ProductRelispray Antifungal Powder
Active ingredientMiconazole Nitrate
Label structure9 sections

Indications and uses

effectively treats most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) relieves itching, scaling, burning and discomfort which may accompany these conditions

Dosage and administration

wash the affected area and dry thoroughly shake can well and 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 spaces between the toes wear well-fitting, ventilated shoes change shoes and socks at least once daily for athlete's foot and ringworm: use daily for 4 weeks for jock itch, use daily for 2 we...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • effectively treats most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • relieves itching, scaling, burning and discomfort which may accompany these conditions

Warnings

WARNINGS SECTION

For external use only

Flammable. Do not use while smoking or near heat or flame.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
  • do not puncture or incinerate. Contents under pressure.
    Do not store at temperatures above 120°F

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash the affected area and dry thoroughly
  • shake can well and 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 spaces between the toes
    • wear well-fitting, ventilated shoes
  • change shoes and socks at least once daily
  • for athlete's foot and ringworm: use daily for 4 weeks
  • for jock itch, use daily for 2 weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, aluminum starch octenyl succinate, isopropyl myristate, propellant (isobutane, normal butane, propane), propylene carbonate, SD alcohol 40-B (10% w/w), sorbitan monooleate, stearalkonium hectorite

Questions or comments?

OTC - QUESTIONS SECTION

Call 888-491-1965

PRINCIPAL DISPLAY PANEL - 128 g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46063-552-12

Relispray
Antifungal
Spray
Powder

Miconazole Nitrate
2% Antifungal
Spray Powder

Net Wt 4.5 oz (128g)

PRINCIPAL DISPLAY PANEL - 128 g Can Label
PRINCIPAL DISPLAY PANEL - 128 g Can Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998428miconazole nitrate 2 % Powder SprayPSN2
998428miconazole nitrate 0.02 MG/MG Powder SpraySCD2
998428miconazole nitrate 2 % Powder SpraySY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46063-552-12Relispray Antifungal Powder128 g in 1 CANAEROSOL, SPRAY1282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46063-552RELISPRAY ANTIFUNGAL POWDER (MICONAZOLE NITRATE) AEROSOL, SPRAY [MIDAS-CARE PHARMACEUTICALS PVT. LTD.]2Legacy NDC, 1 package rows20241220_93434d3e-6fe4-4fe0-be4f-573d183bf527.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46063-55246063-552-12

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
Miconazole NitrateVW4H1CYW1KACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
Isopropyl Myristate0RE8K4LNJSIACT
LIQUEFIED PETROLEUM GAS5K616HU99VIACT
Propylene carbonate8D08K3S51EIACT
ALCOHOL3K9958V90MIACT
Sorbitan monooleate06XEA2VD56IACT
Stearalkonium hectoriteOLX698AH5PIACT

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
4aca3928-9552-426f-8384-6c0abcaa7cb993434d3e-6fe4-4fe0-be4f-573d183bf5272024-12-17WarningsExact identifier
spl id: 4aca3928-9552-426f-8384-6c0abcaa7cb9
spl set id: 93434d3e-6fe4-4fe0-be4f-573d183bf527

Reported adverse events (FAERS/openFDA)#

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