Label: SINSINPAS AREX INSTANT PAIN RELIEF (NOT FOR SALE)- camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch

  • NDC Code(s): 55264-108-01, 55264-108-02
  • Packager: Sinsin Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 5, 2024

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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

    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 DOCTOR

    Ask a doctor before use if you are allergic to any ingredients in this product.

  • WHEN USING

    When using this product

    -do not use other than directed

    -avoid contact with eyes, mucous membranes, and rashes

  • STOP USE

    Stop use and ask a doctor if

    -rash, itching, or excessive skin irritation develops

    -condition worsens

    -symptoms persist for longer than 7 days

    -symptoms clear up and reoccur within a few days

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • WARNINGS AND PRECAUTIONS

    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.

  • 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

    label

  • INGREDIENTS AND APPEARANCE
    SINSINPAS AREX INSTANT PAIN RELIEF (NOT FOR SALE) 
    camphor, mentha oil, menthol, methyl salicylate, zinc oxide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-108
    Route of AdministrationTOPICAL
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-108-021 in 1 CARTON11/06/2020
    1NDC:55264-108-012 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/06/2020
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-108)
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