Omax Cryofreeze Roll-On

Manufacturer
Omax Health, Inc
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:10:38

Label at a glance#

ProductOmax Cryofreeze Roll-On
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

Full-Spectrum Hemp Oil Extract, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camphor, Carbomer, Chondroitin Sulfate, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methyl Paraben, Methylsulfonylmethane, Peppermint Oil, Polysorbate 20, Propylene Glycol, Triethanolamine, Purified Water

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™
CBD
PAIN RELIEF ROLL-ON

3 fl oz / 89 mL

150MG
CBD

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73036-001-012022-01-31C16284748780-1d6a99b39-35cf-a426-e053-dadaa90af4c2Omax Cryofreeze™ Roll-On
73036-001-012022-01-28C16284748780-1d6a99b39-35cf-a426-e053-dadaa90af4c2Omax Cryofreeze™ Roll-On

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73036-00173036-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
a8a8718f-b41f-49c3-9633-a1b9cb2029d77e196915-3cc9-4549-95e1-242c510a39f32022-01-14WarningsExact identifier
spl id: a8a8718f-b41f-49c3-9633-a1b9cb2029d7
spl set id: 7e196915-3cc9-4549-95e1-242c510a39f3

Reported adverse events (FAERS/openFDA)#

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