SINSINPAS AREXLOTION- l-menthol lotion 
Sinsin Pharmaceutical Co., Ltd.

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SINSINPAS AREX LOTION

Active Ingredients

Methyl Salicylate 200.0mg

L-Menthol 60.0mg

Tocopherol Acetate 1.0mg

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

Warnings

For external use only

allergy alert: If prone to allergic reaction from aspirin or salicylates or allergic to any ingredients in this product, consult a doctor before use.

When using this product

stop use and ask a doctor if

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

Keep out of reach of children.

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

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:

repeat as necessary, but no more than 3 to 4 times daily

Children undress 12 years of age: ask a doctor

Other Information

Inactive Ingredients

Nonylic acid vanillyamide, Carbomer 941, Light liquid paraffin, Polysorbate 60, Sorbital Monostearate. Lanolin oil, Triethanolamine, Fresh yuja flavor, Purified water

SINSINPAS AREX LOTION

SINSINPAS AREX LOTION BOTTLESINSINPAS AREX LOTION BOX

SINSINPAS AREXLOTION 
l-menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE1 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL60 mg
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 60 (UNII: CAL22UVI4M)  
LANOLIN OIL (UNII: OVV5IIJ58F)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TROLAMINE (UNII: 9O3K93S3TK)  
CITRUS JUNOS FRUIT (UNII: 53KHW58C1V)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
NONIVAMIDE (UNII: S846B891OR)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55264-112-021 in 1 BOX08/27/2021
1NDC:55264-112-011 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/27/2021
Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
Establishment
NameAddressID/FEIBusiness Operations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-112)

Revised: 1/2024
Document Id: 0e3cb18b-0253-3807-e063-6394a90a3793
Set id: ca93de41-1aa7-7996-e053-2995a90afe6b
Version: 2
Effective Time: 20240105
 
Sinsin Pharmaceutical Co., Ltd.