ICEQUAKE Cold Hot

Manufacturer
Southern Sales & Service, Inc.
Effective date
2019-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:45

Label at a glance#

ProductICEQUAKE Cold Hot
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

WARNINGS

WARNINGS SECTION

For External Use Only.

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Aluminium glycinate,1,3-buthylene Glycol, Carboxymethylcellulose Sodium, Concentrated Glycerin, diethylene Glycolmonoethyl Ether, Disodium Edetate, Methyl Parahydroxybenzoate, Polyacrylic Acid Solution, Polysorbate 80, Propyl Parahydroxybenzoate, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Oxide

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis<br />■ muscle strains ■ muscle sprains ■ bruises ■ cramps

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: Carefully remove backing from patch.

Apply one patch to affected area

Repeat as necessary, but no more than 4 times daily.

Children under 12 years of age: Ask a doctor.

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

When using this product

OTC - WHEN USING SECTION

Use only as directed

■ Do not bandage tightly.

■ Do not use a heating pad.

■ Avoid contact with eyes and mucous membranes.

■ Don’t apply to wounds or damaged skin.

■ Do not use if you are alergic to any ingredients of this product.

Stop use and ask a doctor

OTC - STOP USE SECTION

■ If condition worsens

■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

■ If redness is present

■ If irritation develops

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 right away.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Southern Sales Services Inc
Pembroke Pines, FL 33332

Patch Label Image
Patch Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
420222menthol 5 % Medicated PatchPSN1
420222menthol 0.05 MG/MG Medicated PatchSCD1
420222menthol 5 % Medicated PatchSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-010-042021-01-29C16284748780-1ba0f9c33-10db-a910-e053-dadaa90a0b85ICEQUAKE Cold'n Hot

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-010-04ICEQUAKE Cold Hot4 in 1 BOXPATCH41
69822-010-04ICEQUAKE Cold Hot9 g in 1 PATCHPATCH91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-010ICEQUAKE COLD HOT (MENTHOL) PATCH [SOUTHERN SALES & SERVICE, INC.]1Legacy NDC, 2 package rows20190312_09774bab-f366-412f-a3fc-26f00f44928e.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-01069822-010-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
e11da3ea-8265-4a09-8c9e-6637b0c56abb09774bab-f366-412f-a3fc-26f00f44928e2019-03-11WarningsExact identifier
spl id: e11da3ea-8265-4a09-8c9e-6637b0c56abb
spl set id: 09774bab-f366-412f-a3fc-26f00f44928e

Reported adverse events (FAERS/openFDA)#

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