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
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 8, 2019

If you are a consumer or patient please visit this version.

  • 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 not finalpart34807/26/2013
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-021)