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Drug Facts
Cryofreeze Roll-on Regular Strength
FDA Label NDC 73036-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Omax Health, Inc for the product Cryofreeze Roll-on Regular Strength (NDC 73036-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Natural Menthol, USP (8.5%)
Purpose
Topical Analgesic
Uses
Temporary relief from minor aches and pains from sore muscles and joints, backache, arthritis.
Warnings
For external use only.
Otc - Keep Out Of Reach Of Children
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
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
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
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
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
CRYOFREEZE™
HEMP
PAIN RELIEF ROLL-ON
REGULAR
STRENGTH
3 fl oz / 89 mL
150 MG
Principal Display Panel (89 mL Bottle Label)
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