FDA.reportPublic FDA data

Arctic Ice Analgesic Gel

Manufacturer
ROYAL EXPORTS
Effective date
2018-09-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:01

Label at a glance#

ProductArctic Ice Analgesic Gel
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

temporary relief of minor aches and pains in muscles and joints associated with simple backaches, strains, sprains, arthritis and sports injuries

Dosage and administration

Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • temporary relief of minor aches and pains in muscles and joints associated with simple backaches, strains, sprains, arthritis and sports injuries

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Use only as directed. Avoid contact with eyes or mucous membranes. Do not apply to open wounds or damaged skin. Make sure skin is clean and free from any creams , ointments , sprays or liniment. Do not bandage.

Do not use with heating pads or heating devices

OTC - DO NOT USE SECTION

If condition worsens or symptoms persist for more than 7 days, or if symptoms disappear and occur again within a few days, discontinue use and consult a physician before use. If skin irritation develops, discontinue use and consult a physician. If you are pregnant or nursing a baby, consult your doctor before use. Do not use, store, pour or spoll near heat or open flame. Store in a cool, dry place and keep lid tightly closed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Clean skin of all other lotions, creams, ointments, liniment, or sprays. Apply liberally to affected area and massage until gel is absorbed into skin. Do not apply more than 3 or 4 times daily. No protective cover needed. Do not apply to children under 2 years or age.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alchohol , Nonoxynol-10, Camphor, Carbomer 934, Sodium Hydroxide, Methylchloroisothiazolinone & Methylisothiazolinone, FD&C Blue no. 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG FACT PANELDRUG FACT PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039043menthol 1 % Topical GelPSN1
1039043menthol 0.01 MG/MG Topical GelSCD1
1039043menthol 1 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51328-2050-12021-01-29C16284748780-1ba0f9c33-3024-a910-e053-dadaa90a0b85751296e9-2f35-aa86-e053-2991aa0a54a4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51328-2050-1Arctic Ice Analgesic Gel227 g in 1 JARGEL2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51328-2050ARCTIC ICE ANALGESIC GEL (MENTHOL) GEL [ROYAL EXPORTS]1Legacy NDC, 1 package rows20190330_751296e9-2f35-aa86-e053-2991aa0a54a4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51328-205051328-2050-1

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
ISOPROPYL ALCOHOLND2M416302IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER 934Z135WT9208IACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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
7512601b-f94d-0076-e053-2991aa0a9ca8751296e9-2f35-aa86-e053-2991aa0a54a42018-09-04WarningsExact identifier
spl id: 7512601b-f94d-0076-e053-2991aa0a9ca8
spl set id: 751296e9-2f35-aa86-e053-2991aa0a54a4

Reported adverse events (FAERS/openFDA)#

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