SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH- l-menthol patch

Sinsinpas Arex Flex Gel Pain Relieving Patch by

Drug Labeling and Warnings

Sinsinpas Arex Flex Gel Pain Relieving Patch by is a Otc medication manufactured, distributed, or labeled by Sinsin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Purpose

Topical Analgesic

INDICATIONS & USAGE

For the temporary relief of minor aches and pains of muscles and joints associated with:

• Arthritis
• Simple backache
• Strains
• Bruises
• Sprains

WARNINGS

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

• on wounds or damaged skin
• if you are allergic to any ingredients of this product
• with a heating pad

When using this product

• use only as directed
• avoid contact with eyes, mucous membranes, and rashes

Stop use and ask a doctor if

• skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
• condition worsens
• symptoms persist for longer than 7 days
• symptoms clear up and reoccur within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out or reach of children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

■ clean and dry affected area
■ remove patch from film
■ apply to affected area not more than 3 times daily
■ remove patch from skin after at most 8 hours of application

children under 12 years of age: Consult a doctor

Other Information

■ avoid storing product in direct sunlight
■ protect product from excessive moisture

Inactive Ingredients

Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution,
Concentrated Glycerin, Dihydroxyaluminum, Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH 
l-menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	57.6 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	96 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	76.8 mg

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TARTARIC ACID (UNII: W4888I119H)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
GELATIN (UNII: 2G86QN327L)
CASTOR OIL (UNII: D5340Y2I9G)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
NONIVAMIDE (UNII: S846B891OR)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
KAOLIN (UNII: 24H4NWX5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-116-02	1 in 1 POUCH	05/01/2024
1	NDC: 55264-116-01	6 in 1 PATCH; 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	05/01/2024

Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)

Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)

Establishment
Name	Address	ID/FEI	Business Operations
Sinsin Pharmaceutical Co., Ltd.		687867143	manufacture(55264-116)