Label: SINSINPAS AREX INSTANT PAIN RELIEF SMALL- camphor, menthol, mentha oil, methyl salicylate, zinc oxide patch

  • NDC Code(s): 55264-109-01
  • 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 June 29, 2021

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 in this product.

    When using this product

    • Do not use other than directed
    • Avoid contact with eyes, mucous membranes, and rashes

    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

    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.

  • Keep out of reach of children

    Keep out of reach of children

  • 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

    SINSINPAS AREX SMALL

  • INGREDIENTS AND APPEARANCE
    SINSINPAS AREX INSTANT PAIN RELIEF SMALL 
    camphor, menthol, mentha oil, methyl salicylate, zinc oxide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-109
    Route of AdministrationCUTANEOUS, TOPICAL, 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-109-011 in 1 POUCH06/29/2021
    110 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/29/2021
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-109)