FDA.reportPublic FDA data

ICY COLD COOL PAIN RELIEVING

Manufacturer
COMPASS HEALTH BRANDS CORP. | DIVERSIFIED MANUFACTURING CORP
Effective date
2017-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:19

Label at a glance#

ProductICY COLD COOL PAIN RELIEVING
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure10 sections

Indications and uses

temporary relief of Arthritis Backache Strains/Sprains

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Rub in thoroughly until gel is absorbed.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 3.9%

CAMPHOR 0.4%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

COUNTER IRRITANT

USES

INDICATIONS & USAGE SECTION

temporary relief of

  • Arthritis
  • Backache
  • Strains/Sprains

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

Do not use near eyes, mouth, mucus membranes, genitals, cuts, rashes and sores. If contact occurs, flush with cold water. Do not use with heating pad or device, or under bandages. Do not use if pregnant or breastfeeding. Please consult your physician prior to use. Do not apply to wounds or damaged skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidentally ingested, seek medical help or contact a Poison Control Center immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Rub in thoroughly until gel is absorbed.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Propylene Glycol, Glycerin, Carbomer, Ilex Paraguariensis Leaf Extract, Hydrated Silica, Aminomethyl Propanol, Methyl Paraben, Uncaria Tomentosa Extract, Boswelia Serrata Extract, Camphor for scent.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Thera Med Icy Cold Cool Pain Relieving Gel ( 16oz.)Thera Med Icy Cold Cool Pain Relieving Gel ( 16oz.)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1874891camphor 0.4 % / menthol 3.9 % Topical GelPSN1
1874891camphor 0.004 MG/MG / menthol 0.039 MG/MG Topical GelSCD1
1874891camphor 0.4 % / menthol 3.9 % Topical GelSY1

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
71323-101-052022-01-28C16284748780-1d6a99b39-cfee-a426-e053-dadaa90af4c24362fc73-a534-472b-bb09-e0237a1e4ab3
71323-101-132022-01-28C16284748780-1d6a99b39-cfee-a426-e053-dadaa90af4c24362fc73-a534-472b-bb09-e0237a1e4ab3
71323-101-142022-01-28C16284748780-1d6a99b39-cfee-a426-e053-dadaa90af4c24362fc73-a534-472b-bb09-e0237a1e4ab3
71323-101-262022-01-28C16284748780-1d6a99b39-cfee-a426-e053-dadaa90af4c24362fc73-a534-472b-bb09-e0237a1e4ab3
71323-101-912022-01-28C16284748780-1d6a99b39-cfee-a426-e053-dadaa90af4c24362fc73-a534-472b-bb09-e0237a1e4ab3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71323-101-05ICY COLD COOL PAIN RELIEVING5 mL in 1 POUCHGEL51
71323-101-13ICY COLD COOL PAIN RELIEVING88.8 mL in 1 BOTTLEGEL88.81
71323-101-14ICY COLD COOL PAIN RELIEVING118 mL in 1 BOTTLEGEL1181
71323-101-26ICY COLD COOL PAIN RELIEVING473 mL in 1 BOTTLEGEL4731
71323-101-91ICY COLD COOL PAIN RELIEVING3785 mL in 1 JUGGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71323-101ICY COLD COOL PAIN RELIEVING (MENTHOL, CAMPHOR) GEL [COMPASS HEALTH BRANDS CORP.]1Legacy NDC, 5 package rows20170322_4362fc73-a534-472b-bb09-e0237a1e4ab3.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71323-10171323-101-26, 71323-101-91, 71323-101-13, 71323-101-14, 71323-101-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
SILICONZ4152N8IUIIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
METHYLPARABENA2I8C7HI9TIACT
UNCARIA TOMENTOSA WHOLEU6P1SV66LAIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT

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
7a9eefa7-6163-46ef-88c3-871c1ba7d2ac4362fc73-a534-472b-bb09-e0237a1e4ab32017-03-22WarningsExact identifier
spl id: 7a9eefa7-6163-46ef-88c3-871c1ba7d2ac
spl set id: 4362fc73-a534-472b-bb09-e0237a1e4ab3

Reported adverse events (FAERS/openFDA)#

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