FDA.reportPublic FDA data

Touchless Care ANTIFUNGAL SPRAY

Manufacturer
Crawford Healthcare, Inc.
Effective date
2017-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:56

Label at a glance#

ProductTouchless Care ANTIFUNGAL
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Dosage and administration

Cleanse the affected area and allow to dry. Shake bottle well before use. Spray 4-6 inches from skin twice daily (morning and night) or as directed by a physician. No rub-in is required. For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, contact a doctor. This product is not effective on the scalp or nails.

Storage and handling

Store at 59 o F - 87 o F (15 o C - 30 o C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Indications

INDICATIONS & USAGE SECTION

  • Treats jock itch, ringworm and athlete's foot
  • For the treatment of most superficial skin irritations caused by yeast (Candida albicans). Follow a physician's instructions when treating Candida.

Warnings

WARNINGS SECTION

Do not use on children under 2 years of age unless directed by a doctor. Not intended for ingestion. Do not use for diaper rash. For external use only. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation develops
  • there is no improvement within 4 weeks for athlete's foot or ringworm or within 2 weeks for 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

  • Cleanse the affected area and allow to dry.
  • Shake bottle well before use.
  • Spray 4-6 inches from skin twice daily (morning and night) or as directed by a physician. No rub-in is required.
  • For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, contact a doctor. This product is not effective on the scalp or nails.

Other Information

STORAGE AND HANDLING SECTION

Store at 59 oF - 87 oF (15 oC - 30 oC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cyclomethicone, Dimethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, White Petrolatum, Zinc Oxide

SPL Unclassified Section

Distributed by: Crawford Healthcare, Inc. Doylestown, PA 18901

Touchless Care is a registered trademark of Crawford Woundcare Ltd.

© Crawford Healthcare Ltd., 2016

www.crawfordhealthcare.com/us

1-855-522-2211

Made in the USA

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antifungal label

antifungal labelantifungal label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998533miconazole nitrate 2 % Topical SprayPSN1
998533miconazole nitrate 20 MG/ML Topical SpraySCD1
998533miconazole nitrate 2 % Topical SpraySY1
998533miconazole nitrate 3 GM in 150 GM Topical SpraySY1

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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69502-001-572022-01-28C16284748780-1d6a99b39-9c4f-a426-e053-dadaa90af4c2Touchless Care ANTIFUNGAL SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69502-001-57Touchless Care ANTIFUNGAL57 g in 1 BOTTLE, SPRAYSPRAY571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69502-001TOUCHLESS CARE ANTIFUNGAL SPRAY [CRAWFORD HEALTHCARE, INC.]1Legacy NDC, 1 package rows20170228_48a7a01e-3480-45bf-e054-00144ff88e88.zip

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
69502-00169502-001-57

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
LANOLIN7EV65EAW6HIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
MINERAL OILT5L8T28FGPIACT
DIMETHICONE92RU3N3Y1OIACT
CYCLOMETHICONENMQ347994ZIACT
PETROLATUM4T6H12BN9UIACT
ZINC OXIDESOI2LOH54ZIACT
HEXAMETHYLDISILOXANED7M4659BPUIACT
CHOLECALCIFEROL1C6V77QF41IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT

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
48a7a01e-3481-45bf-e054-00144ff88e8848a7a01e-3480-45bf-e054-00144ff88e882017-02-16WarningsExact identifier
spl id: 48a7a01e-3481-45bf-e054-00144ff88e88
spl set id: 48a7a01e-3480-45bf-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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