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

ASYSTEM Radical Relief Gel Roll-On by

Drug Labeling and Warnings

ASYSTEM Radical Relief Gel Roll-On by is a Otc medication manufactured, distributed, or labeled by Cosco International, Inc., Cosco International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-4902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.10 kg  in 1 kg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.15 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-4902-1	1 in 1 CARTON	07/03/2023
1		0.075 kg in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/03/2023

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc		016433141	manufacture(52261-4902) , label(52261-4902) , pack(52261-4902)