Label: BT PAIN RELIEF- menthol, methyl salicylate patch

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

Drug Label Information

Updated November 22, 2023

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

  • Drug Facts

  • Active Ingredients

    Menthol 5%
    Methyl Salicylate 1%

  • Purpose

    External analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles associated with

    •strains •bruises •sprains •simple backache •cold and dampness

  • Warnings

    For external use only

    Do not use

    •on wounds •irritated or damaged skin •sensitive skin

    •with a heating pad •if pregnant

    •with, or as the same time as, other external analgesic products

    •if allergic to aspirin or salicylates

    •if allergic to any ingredients of this product

    When using this product

    •avoid contact with the eyes

    •do not bandage tightly

    •do not apply to wounds or damaged skin

    •do not use more than 2 plasters a day

    •do not use 1 hour before or after bathing

    Stop use and ask a doctor if

    •condition worsens

    •symptoms persist for more than 7 days

    •symptoms clear up and occur again within a few days

    •excessive irritation of the skin develops

    •rashes, itching or redness are present

    •side effects occur

    If pregnant, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of childrento avoid accidental poisoning.
    In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use otherwise than as directed.

  • Directions

    • Clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.
    •Patch will remain effective for 6 hours.
    •Avoid using the same patch on the same area for more than 6 hours.
    •Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.
    •Wet patch with warm water before removing from skin
    •Children under 2 years of age: Do not use or consult a doctor.

  • Other information

    •Store unused patch in the pouch
    •Store at room temperature, 20° to 25° C (68°  to 77° F)

  • Inactive ingredients

    Cinnamomum kanehirae Hayata Essential Oil, Chinese Clematidis Root & Rhizome, Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No. 2, FD&C Yellow No. 4, Zinc Oxide

  • QUESTIONS

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  • SPL UNCLASSIFIED SECTION

    Distributed by

    Big 5 Nutrition LLC

    Made in Taiwan

  • Packaging

    LABEL

  • INGREDIENTS AND APPEARANCE
    BT PAIN RELIEF 
    menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82198-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.06 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
    INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)  
    MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
    MYRRH (UNII: JC71GJ1F3L)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    PINUS MASSONIANA RESIN (UNII: 64S07U83T7)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    SESAME OIL (UNII: QX10HYY4QV)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Product Characteristics
    ColorgreenScore    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82198-0011-13 in 1 BAG01/01/2024
    15.9 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/01/2024
    Labeler - Big 5 Nutrition LLC (114574559)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.656348265manufacture(82198-0011) , label(82198-0011) , pack(82198-0011)