SINSINPAS AREXGEL- l-menthol patch

SINSINPAS AREXGEL by

Drug Labeling and Warnings

SINSINPAS AREXGEL 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

Uses

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

• Arthritis
• Simple backache
• Strains
• Bruises
• Sprains

Warnings

For external use only

Do not use

• on wounds or damaged skin
• if you are allergic to any ingredients of this product
• with a heating pad
• with, or at the same time as, other external analgesic products

Ask a doctor before use if you are allergic to any ingredients in this product.

When using this product

• do not use other than directed
• avoid contact with eyes, mucous membranes, and rashes

Stop use and ask a doctor if

• rash, itching, or excessive skin irritation develops
• 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.

Caution: This product contains natural rubber latex which may cause allergic reactions.

Keep out of reach of children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 no more than 3 to 4 times daily for 7 days
• Remove patch from skin after at most 8 hours’ application

Children undress 12 years of age: consult a doctor

Other Information

• Avoid storing product in direct sunlight
• Protect from excessive moisture

Inactive Ingredients

Aloe vera gel, Butylated hydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Dihydroxyalumium Aminoacetate, Gelatin, Kaolin, Methylparaben, Nonivamide, Polysorbate 80, Purified water, Sodium polyacrylate, Sorbitol, Tartaric acid, Titanium dioxide

SINSINPAS AREX GEL PATCH

INGREDIENTS AND APPEARANCE

SINSINPAS AREXGEL 
l-menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-114
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-114-02	1 in 1 POUCH	08/27/2021
1	NDC: 55264-114-01	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	08/27/2021

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(55264-114)