FDA.reportPublic FDA data

C.D.M.A Icy Cool

Manufacturer
Sklar BOV Solutions Inc | Sklar BOV Solutions, Inc
Effective date
2022-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:50

Label at a glance#

ProductC.D.M.A Icy Cool
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpos

Menthol 10.5% Topical Analgesic

OTC - PURPOSE SECTION

Uses - Topical Analgesic

INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE

Temporary relief form minor aches and pains of sore muscles and joints associated with arthritis backache, strains and sprains

WARNINGS SECTION

Warning

FOR EXTERNAL USE ONLY. Flammaable. Keep away form excessive heat of open flame. CONTENTS UNDER

PRESSURE. DO NOT PUNCTURE OR INCINERATE. DO NOT STORE AT TEMPERATURE ABOVE 120°F.

WARNINGS AND PRECAUTIONS SECTION

When using this product; Avoid contact with eyes or mucous membranes. Do not apply to wounds or damages skin.

Do not use with others sprays, ointments, creams, sprays of liniments. Do not apply to irritated skin or if excessive

irritation develops. Do not bandage. Wash hands after use with cold water. Do not use with heating pad or device.

OTC - STOP USE SECTION

Stop Use and Ask a Doctor if: Condition worsens. If symptoms persist for more than 7 days, of if symptons clean up and

reoccur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children. If swallowed, het medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If Pregnant of Breastfeeding; Consult a doctor before use.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and Children 12 years of age and older. Spray on the affected areas not more than 4 times daily, massage not

necceeary. Children under 12 years of age, Consult Physicial

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Inactive Ingredients: Alcohol Denat., Arnica Montana Flower Extract. Calendula Officinalis Flower Extract, Camellia

Sinensis Leaf Extract, Chamomilla Recultita (Matricana) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Augustifola

Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

OTC - QUESTIONS SECTION

Distributed by C.D.M.A. Inc.©

43157 W 9 Mile Rd

Novi, NI 48375

www.qualitychoice.com

Questions: 248-449-9300

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Icy Cool LabelIcy Cool Label85 grams NDC52313-1131-1

Maximum Strength

Icy Cool™

Pain Relieving Spray

Menthol 10.5 % | Topical Analgesic

Relief from Aches and Pains Associated with Strains, Sprains, Simple Bachaches, Bruses and Arthritus

Quatity Choice®

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489073menthol 10.5 % Topical SprayPSN2
1489073menthol 105 MG/ML Topical SpraySCD2
1489073menthol 10.5 % Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52313-1131-12024-01-30C16284748780-1d6a99b39-f625-a426-e053-dadaa90af4c2C.D.M.A. Icy Cool
52313-1131-12022-01-31C16284748780-1d6a99b39-f625-a426-e053-dadaa90af4c2C.D.M.A. Icy Cool
52313-1131-12022-01-28C16284748780-1d6a99b39-f625-a426-e053-dadaa90af4c2C.D.M.A. Icy Cool

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52313-1131-1C.D.M.A Icy Cool85 g in 1 CANSPRAY852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52313-1131C.D.M.A ICY COOL (COLD THERAPY MUSCLE) SPRAY [SKLAR BOV SOLUTIONS INC]2Legacy NDC, 1 package rows20220201_a85c0383-0a0d-0552-e053-2995a90a37ae.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52313-113152313-1131-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
JUNIPERUS COMMUNIS WHOLE464910T5N9IACT
CHAMOMILEFGL3685T2XIACT
ALCOHOL3K9958V90MIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
WATER059QF0KO0RIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT

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
d6e70a10-c94d-d82b-e053-2a95a90acfbaa85c0383-0a0d-0552-e053-2995a90a37ae2022-01-31WarningsExact identifier
spl id: d6e70a10-c94d-d82b-e053-2a95a90acfba
spl set id: a85c0383-0a0d-0552-e053-2995a90a37ae

Reported adverse events (FAERS/openFDA)#

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