Label: SINSINPAS PAIN RELIEVING PATCH- dl-camphor, l-menthol, methyl salicylate patch

  • NDC Code(s): 55264-101-01, 55264-101-02, 55264-101-03
  • 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 14, 2018

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  • Active Ingredients

    DL-Camphor (1.21%)

    L-Menthol (5.54%)

    Methyl Salicylate (6.11%)

  • Purpose

    Topical Analgesic

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Uses

    For the temporarily 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 any ingredients of this product
    • with a heating pad
    • with, or at the same time as, other external analgesic products

    When using this product

    • do not use otherwise than directed
    • avoid contact with eyes, mucous membranes or rashes
    • do not bandage tightly

    Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates

    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.

  • Directions

    Adults and children 12 years of age and over:

    • Clean and dry affected area
    • Remove patch from film
    • Apply to affected area no more than 3 to 4 times daily for 7 days
    • Remove patch from skin after at most 8 hours’ application

    Children undress 12 years of age: consult a doctor

  • Inactive Ingredients

    Butylated Hydroxytoluene, Ester Gum, Natural Rubber, Polybutene, Polyisobutylene, Precipitated Calcium Carbonate, Quintone, Sorbitan Stearate, Tocopherol Acetate, YS Resin, Zinc Oxide

  • SINSINPAS Pain Relieving Patch

    SINSIN PAIN RELIEVING PATCH

  • INGREDIENTS AND APPEARANCE
    SINSINPAS PAIN RELIEVING PATCH 
    dl-camphor, l-menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.56 g  in 459.93 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL25.48 g  in 459.93 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE28.1 g  in 459.93 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    QUINONE (UNII: 3T006GV98U)  
    GLYCERYL ABIETATE (UNII: 2F22LY70Q1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-101-032 in 1 PACKAGE05/01/2017
    1NDC:55264-101-0220 in 1 POUCH
    1NDC:55264-101-01459.93 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2017
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-101)
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