CRYOFREEZE ROLL-ON EXTRA STRENGTH- menthol, unspecified form gel 
Omax Health, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cryofreeze™ Roll-On Extra Strength

Drug Facts

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.

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

EXTRA
STRENGTH

3 fl oz / 89 mL

500 MG

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label
CRYOFREEZE ROLL-ON EXTRA STRENGTH 
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73036-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM85 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
HEMP (UNII: TD1MUT01Q7)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)  
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73036-004-0189 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product03/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/16/2022
Labeler - Omax Health, Inc (965730778)

Revised: 3/2022
Document Id: 64a930f4-cdcb-4f10-bcce-8165ff87acdc
Set id: 61fbc467-c64f-4635-8abb-5dbd5a969179
Version: 1
Effective Time: 20220318
 
Omax Health, Inc