ASYSTEM RADICAL RELIEF GEL ROLL-ON- menthol, methyl salicylate gel 
Cosco International, 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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ASYSTEM Radical Relief Gel Roll-On 

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

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

Questions?

info@asystem.com

75ml label

75ml carton label

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)

Revised: 7/2023
Document Id: 6e95a6c7-5365-48a3-9af2-243ab24b62f5
Set id: 7239733e-5510-4a63-96c3-dd88b4a431a3
Version: 1
Effective Time: 20230703
 
Cosco International, Inc.