Label: GINSENGGO- camphor, menthol, methyl salicylate patch

  • 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 13, 2020

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  • Active ingredients

    DL-Camphor 0.70%

    L-Menthol 1.40%

    Methyl Salicylate 2.80%

  • Purpose

    Topical Analgesic

  • Uses

    for temporary relief of minor pain associated with:

    • Arthritis
    • Simple backache
    • Tendonitis
    • Muscle strains
    • Muscle sprains
    • Bruises
  • Warnings

    For external use only.

    • If pregnant or breast feeding, consult a healthcare professional.
    • Allergy Alert: If you are allergic to any ingredients of this product, ask a doctor before use.
  • Do not use

    • on wounds or damaged skin
    • with, or at the same time as, other external analgesic products.

    When using this product

    • use only as directed
    • do not bandage tightly or use with heating pad.
    • avoid contact with the eyes and mucous membranes.

    Stop use and ask a doctor if

    • conditions worsens.
    • symptoms persist more than 7 days or clear up and occur again within a few days.
    • rash, itiching, or excessive irritation develops.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and older

    • clean and dry affected area
    • remove patch from film.
    • apply to affected area not more than 3 to 4 times daily for 7 days.

    Children under 12 years of age consult a doctor


    Reseal pouch containing used portion patched

  • Other information

    • avoid storing product in direct sunlight
    • protect product from excessive moisture
  • Inactive ingredients

    Butylated Hydroxy Toluene, Butyl Paraben, Carboxymethylcellulose sodium, Castor Oil, Concentrated Glycerin, D-Sorbitol Solution, Disodium Edetate, Gelatin, Kaolin, Magnesium Aluminometasilicate, Methyl paraben, Phellodendron Bark Extract, Polyethylene glycol Monostearate, Polyvinyl Alcohol, Purified Water, Sodium Polyacrylate, Tartaric acid

  • How To Apply

    1. Pull off printed paper

    2. Peel off protective film

    3. Gently apply medicated pad in the affected area

    4. Pull off the remaining paper

  • Manufactured by:

    SINSIN PHARM. CO., LTD.

    http://www.sinsin.com    tel: 82-31-776-1140~3

    776-6, Wonsi-Dong, Danwon-Gu, Ansan City, Kyunggi-Do, Korea

    Made in Korea

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    GINSENGGO 
    camphor, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-005
    Route of AdministrationTOPICAL, CUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.7 mg
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL1.4 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    SILODRATE (UNII: 9T3UU8T0QK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-005-061 in 1 CARTON11/13/2020
    1NDC:55264-005-016 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/22/2013
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-005)
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