Cool Hot Ice Analgesic Gel

Manufacturer
SHIELD LINE LLC
Effective date
2019-05-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:31

Label at a glance#

ProductCool Hot 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

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039043menthol 1 % Topical GelPSN2
1039043menthol 0.01 MG/MG Topical GelSCD2
1039043menthol 1 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52410-0201-22021-01-29C16284748780-1ba0f9c33-3099-a910-e053-dadaa90a0b8535d523ac-85df-3a92-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-0201-2Cool Hot Ice Analgesic Gel227 g in 1 JARGEL2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-0201COOL HOT ICE ANALGESIC GEL (MENTHOL) GEL [SHIELD LINE LLC]2Legacy NDC, 1 package rows20190525_35d523ac-85df-3a92-e054-00144ff8d46c.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
52410-020152410-0201-2

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
89a5a583-e8a5-5ae6-e053-2a95a90aa34835d523ac-85df-3a92-e054-00144ff8d46c2019-05-24WarningsExact identifier
spl id: 89a5a583-e8a5-5ae6-e053-2a95a90aa348
spl set id: 35d523ac-85df-3a92-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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