Label: CRYOFREEZE ROLL-ON REGULAR STRENGTH- menthol, unspecified form gel

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated March 18, 2022

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  • SPL UNCLASSIFIED SECTION

    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

    REGULAR
    STRENGTH

    3 fl oz / 89 mL

    150 MG

    PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CRYOFREEZE ROLL-ON REGULAR STRENGTH 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73036-003
    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:73036-003-0189 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)
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