Arnica Ice Cooling

Manufacturer
Kyron Laboratories (pty) Ltd
Effective date
2016-05-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:08

Label at a glance#

ProductArnica Ice Cooling
Active ingredientCAMPHOR (NATURAL), MENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

Avoid contact with open wounds, eyes or mucus membrains. If excessive skin irritation develops. Wash with water and discontinue use.
Consult a doctor if injuries are severe.

OTC - PURPOSE SECTION

Muscular relief cooling gel

OTC - ACTIVE INGREDIENT SECTION

ARNICA OIL
CAMPHOR
WITCH HAZEL
MENTHOL CRYSTALS

INACTIVE INGREDIENT SECTION

CARBOPOL 990
WATER
POLYSORBATE 80
METHYL HYDROXYBENZOATE
PROPYL HYDROXYBENZOATE
TRIETHANOLAMINE 85%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, animals and uniformed persons.
Although this remedy has been extensively tested under a wide variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek advice and notify the registration holder.
This medicine has not been evaluated by the MCC.
This medicine is not intended to diagnose, treat, cure or prevent any disease.

DOSAGE & ADMINISTRATION SECTION

Use only as directed

INDICATIONS & USAGE SECTION

indications and usage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70674-001-012020-01-31C16284748780-19d75b9cf-e996-f424-e053-dadaa90a57ce8151ecdf-ca41-420e-8e4c-196c66350314
70674-001-022020-01-31C16284748780-19d75b9cf-e996-f424-e053-dadaa90a57ce8151ecdf-ca41-420e-8e4c-196c66350314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70674-001-01Arnica Ice Cooling475 mg in 1 JARGEL4751
70674-001-02Arnica Ice Cooling100 mg in 1 PACKAGEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70674-001ARNICA ICE COOLING (CAMPHOR MENTHOL) GEL [KYRON LABORATORIES (PTY) LTD]1Legacy NDC, 2 package rows20160527_8151ecdf-ca41-420e-8e4c-196c66350314.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70674-00170674-001-01, 70674-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
3867d52f-6186-44ad-8292-49514cf6ba938151ecdf-ca41-420e-8e4c-196c663503142016-05-23WarningsExact identifier
spl id: 3867d52f-6186-44ad-8292-49514cf6ba93
spl set id: 8151ecdf-ca41-420e-8e4c-196c66350314

Reported adverse events (FAERS/openFDA)#

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