Label: PRO-SERO PAIN RELIEF- 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 September 24, 2020

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  • Active ingredients

    Drug FactsMenthol 4%

    Methyl Salicylate 1%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

    • arthritis
    • simple backache
    • sprains
    • strains
    • bruises
  • Warnings

    For external use only

    Alergy alert:

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    Do not use

    • on the face or rashes
    • on wounds or damaged skin
    • if allergic to any ingredient of this product
    • on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if

    • you are allergic to topical products

    When using this product

    • wash hands after applying or removing patch
    • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    • rash, itching or skin irritaion develops
    • condition worsens
    • symptoms last 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

    Keep our of reach of children. Package not child resistant.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • Directions

    Adults and children 12 years of age and over:

    • clean and dry affected area
    • remove patch from film and apply to affected area
    • leave in place for up to 8 to 12 hours
    • apply a new patch up to 3 times daily
    • Children under 12 years of age: Consult a doctor
  • Other information

    • store at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit)
    • avoid storing product in direct sunlight
    • protect product from excessive moisture
    • reseal unused patches in their pouch
    • for some individuals, pain relief begins several hours after applying the patch
  • Inactive ingredients

    Clematis Chinensis Root, FD&C Yellow No. 5, Frankincense, Indigotindisulfonate Sodium, Momordica Cochinchinensis Seed, Myrrh, Ricinus Communis Seed, Rosin, Sesame Oil, Yellow Wax, Zinc Oxide

  • Questions or comments?

    Visit www.pro-sero.com

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  • INGREDIENTS AND APPEARANCE
    PRO-SERO PAIN RELIEF 
    menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80846-100
    Route of AdministrationTOPICAL, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE24 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL96 mg
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV)  
    CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)  
    MYRRH (UNII: JC71GJ1F3L)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
    PINUS MASSONIANA RESIN (UNII: 64S07U83T7)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80846-100-408 in 1 BOX10/12/2020
    15 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2020
    Labeler - Tieh Leh Biotech Co., Ltd. (656113256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tieh Leh Biotech Co., Ltd.656113256manufacture(80846-100)
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