FDA.reportPublic FDA data

Cryofreeze Roll-On Regular Strength

Manufacturer
Omax Health, Inc
Effective date
2022-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:48

Label at a glance#

ProductCryofreeze Roll-On Regular Strength
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

Temporary relief from minor aches and pains from sore muscles and joints, backache, arthritis.

Dosage and administration

Use only as directed. Do not use on children under 12 years of age. Roll onto affected area no more than four times daily.

Storage and handling

Questions call 1-800-765-6691. Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, colors may vary.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Natural Menthol, USP (8.5%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains from sore muscles and joints, backache, arthritis.

Warnings

WARNINGS SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Flammable: Keep out of reach of children.

Contact a doctor before using if have sensitive skin or are pregnant, breastfeeding or on any medications. If swallowed get medical help or call Poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Use only as directed. Do not use on children under 12 years of age. Roll onto affected area no more than four times daily.

When using this product

OTC - WHEN USING SECTION

Do not use with heating pad. Do not bandage. Wash hands with cold water immediately after use and do not touch eyes or mucous membranes. Stop use and ask a doctor if redness or irritation occurs, if condition worsens, or if pain persists for more than 7 days or clears up, then reoccurs.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camphor, Industrial Hemp Extract, Carbomer, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis Extract, Isopropyl Alcohol, Methyl Sulfonylmethane, Peppermint Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Purified Water, Triethanolamine. No Parabens.

Other Information

STORAGE AND HANDLING SECTION

Questions call 1-800-765-6691. Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, colors may vary.

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CRYOFREEZE™
HEMP
PAIN RELIEF ROLL-ON

REGULAR
STRENGTH

3 fl oz / 89 mL

150 MG

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label

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
73036-003-012024-01-30C16284748780-11030e365-16b0-111a-e063-dadaa90a10e2Cryofreeze™ Roll-On Regular Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73036-003-01Cryofreeze Roll-On Regular Strength89 mL in 1 BOTTLE, WITH APPLICATORGEL891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73036-003CRYOFREEZE ROLL-ON REGULAR STRENGTH (MENTHOL, UNSPECIFIED FORM) GEL [OMAX HEALTH, INC]1Legacy NDC, 1 package rows20220322_3bc86fad-06fa-4874-8107-2ddd950cd7db.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73036-00373036-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA WHOLEO80TY208ZWIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
HEMPTD1MUT01Q7IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CHONDROITIN SULFATE (SHARK)2ZAJ1K50XHIACT
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE15VQ11I66NIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEPPERMINT OILAV092KU4JHIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
d0f5ae7c-a5ab-486c-bbd1-453c65edab643bc86fad-06fa-4874-8107-2ddd950cd7db2022-03-18WarningsExact identifier
spl id: d0f5ae7c-a5ab-486c-bbd1-453c65edab64
spl set id: 3bc86fad-06fa-4874-8107-2ddd950cd7db

Reported adverse events (FAERS/openFDA)#

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