AREX SINSIN PAS- camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch 
Sinsin Pharmaceutical Co., Ltd.

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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Arex Sinsin Medium

Active ingredients

DL-Camphor 17.05mg

L-Menthol 45.45mg

Mentha Oil 22.73mg

Methyl Salicylate 45.45mg

Zinc Oxide 215.91mg

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only.

Do not use

Ask a doctor before use

if you are allergic to any ingredients of this product

When using this product

  • do not use otherwise than directed.
  • avoid contact with the eyes, mucous membranes or rashes.

Stop use and ask a doctor if

  • rash, itching or excessive skin irritation develops.
  • conditions worsen.
  • symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days.

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.

Caution:

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

Directions

Adults and children 12 years of age and over:

Children under 12 years of age:

Other information

Inactive ingredients

Benzyl Nicothinamide, Butylated Hydroxytoluene, Calcium Carbonate, Glyceryl Rosinate, Natural Rubber, Polyisobutylene, Polybutene, Quintone, Vanillyl Nonylamide, YS Resin.

FDA NDC No.: 55264-020-10

Distributed by

SINSIN PHARM AMERICA

Brea, CA 92821

www.sinsinpas.us

Principal Display Panel

arex

AREX SINSIN PAS 
camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-020
Route of AdministrationTOPICAL, CUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)17.05 mg
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL22.73 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL45.45 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE45.45 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE215.91 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL NICOTINAMIDE (UNII: HF1W0213QP)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
GLYCERIN (UNII: PDC6A3C0OX)  
ROSIN (UNII: 88S87KL877)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
POLYISOBUTYLENE (200000 MW) (UNII: Z6Y02I0591)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
NONIVAMIDE (UNII: S846B891OR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55264-020-101 in 1 CARTON11/09/2018
110 in 1 POUCH; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2015
Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
Establishment
NameAddressID/FEIBusiness Operations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-020)

Revised: 11/2019
Document Id: 96d2bcf2-fe79-8866-e053-2a95a90a5e90
Set id: 2013ea44-e2ea-4b36-bddb-7f64163284b6
Version: 6
Effective Time: 20191108
 
Sinsin Pharmaceutical Co., Ltd.