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
  • 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 March 17, 2021

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

  • 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 not finalpart34811/06/2020
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-108)