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

  • NDC Code(s): 55264-021-06
  • Packager: Sinsin Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 7, 2025

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  • Active ingredients

    DL-Camphor 34.10mg

    L-Menthol 90.90mg

    Mentha Oil 45.46mg

    Methyl Salicylate 90.90mg

    Zinc Oxide 431.82mg

  • 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.

    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:

    • 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.: 55264-021-06

  • Distributed by:

    SINSIN PHARM AMERICA

    Brea, CA 92821

    www.sinsinpas.us

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    AREX SINSIN PAS 
    camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-021
    Route of AdministrationTOPICAL, CUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)34.1 mg
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL45.46 mg
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL90.9 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE90.9 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE431.82 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:55264-021-061 in 1 CARTON11/09/2018
    16 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 DrugM01707/26/2013
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-021)
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