Label: BT PAIN RELIEF- menthol, methyl salicylate spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2023

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  • Drug Facts

  • Active Ingredients

    Menthol 10%

    Methyl Salicylate 5%

  • Purpose

    External analgesic

  • Uses

    For temporary relief of joint and muscles aches and pains

    • sprains and strains
    • inflammation
    • mild bruises
  • Warnings

    For external use only

    • Use only as directed
    • Avoid contact with the eyes or mucous membranes
    • Do not use on open wounds or irritated or broken skin.
    • Discontinue use if skin rash or irritation develops or if condition worsens.
    • Consult your doctor before use if you are pregnant or breast feeding.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Clean and dry application area. Spray treatment directly onto skin and gently rub in if desired. May be used up to 10 times per day in adults and children over age 2.

  • Other Information

    • Store at room temperature
    • Shake well before use, close cap tightly after use
    • Read all product information before use
  • Inactive Ingredients

    Cinnamomum kanehirae Hayata Essential Oil, Saposhnikoviae Radix, Artemisia Argyi Folium, Moutan Cortex, Cimicifugae Rhizoma, Sophorae Flavescentis Radix, Paeoniae Radix, Rubra Notoginseng Radix et Rhizoma, Carthami Flos, Alcohol.

  • Questions or Comments?

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  • SPL UNCLASSIFIED SECTION

    Distributed by

    Big 5 Nutrition LLC

    Made in Taiwan

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BT PAIN RELIEF 
    menthol, methyl salicylate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82198-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)  
    PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)  
    ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT)  
    Product Characteristics
    Colorbrown (Light Brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82198-0012-170 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2024
    Labeler - Big 5 Nutrition LLC (114574559)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.656348265manufacture(82198-0012) , label(82198-0012) , pack(82198-0012)
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