Label: ASYSTEM RADICAL RELIEF GEL ROLL-ON- menthol, methyl salicylate gel

  • NDC Code(s): 52261-4902-1
  • Packager: Cosco International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 July 3, 2023

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  • DRUG FACTS

    Menthol - 10% (External Analgesic)
    Methyl Salicylate (NSAID) – 15% (External Analgesic)

    External Analgesic

  • Uses:

    For temporary relief of the minor aches and pains of muscles and joints associated with backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation.

  • Warnings:

    For External Use Only

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center immediately.

    Do not use: on wounds or damaged skin, with a heating pad, on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have redness over the affected area.

    Avoid contact with eyes.  If contact occurs, flush throughly with water.

  • Directions:

    Use only as directed.  Apply generously and massage to affected area as needed.  Do not use more than 3 to 4 times per day.  Children under 12 years of age ; ask a doctor before use.

  • Inactive Ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethylpropanol, Arnica Montana Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Glyceryl Stearate/PEG-100 Stearate, Isopropyl Myristate, Magnesium Hydroxide, Maritime Pine, Phenoxyethanol, Polysorbate 80, Tocopherol Acetate, Water

  • OTHER SAFETY INFORMATION

    Allery Alert:  Do not use if you are allergic to salicylates (including aspritin) without consulting a physician.

  • Questions?

    info@asystem.com

  • PRINCIPAL DISPLAY PANEL

    75ml label

  • PRINCIPAL DISPLAY PANEL

    75ml carton label

  • INGREDIENTS AND APPEARANCE
    ASYSTEM RADICAL RELIEF GEL ROLL-ON 
    menthol, methyl salicylate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-4902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.10 kg  in 1 kg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.15 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-4902-11 in 1 CARTON07/03/2023
    10.075 kg in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/03/2023
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc016433141manufacture(52261-4902) , label(52261-4902) , pack(52261-4902)
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