Label: AREX SINSIN PAS- camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch

  • NDC Code(s): 55264-020-10
  • Packager: Sinsin Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated February 23, 2023

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  • 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:

    • arthritis
    • simple backache
    • strains
    • bruises
    • sprains
  • Warnings

  • For external use only.

  • Do not use

    • on wounds or damaged skin
    • if you are allergic to aspirin or salicylates
    • 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 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.

    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:

    • Clean and dry affected area
    • Remove patch from film.
    • Apply to affected area not more than 3 to 4 times daily for 7 days.
    • Remove patch from skin after at most 8 hours application.

    Children under 12 years of age:

    • Consult a doctor.
  • Other information

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

  • Manufactured by:

    SINSIN PHARM. CO., LTD.

    90, Beomjigi-ro 141 beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea

    tel: 82-31-776-1140~3 http://www.sinsin.com

  • Principal Display Panel

    arex

  • INGREDIENTS AND APPEARANCE
    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)
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