Label: QUALI HERBAL- 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 October 12, 2016

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  • ACTIVE INGREDIENTS

    Menthol   10%

    Methyl Salicylate   0.5%

  • Purpose

    Menthol         Topical Analgesic

    Methyl Salicylate       Topical Analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

    Simple backache
    Arthritis
    Sprains
    Strains
    Bruises

  • Warnings

    1. For external use only. Avoid applying around the eyes and mucous membranes, or open wounds.
    2. Pregnant women, nursing mothers and any person with allergic reactions to drugs or cosmetics should consult physician before use. Children should use this product under supervision.

  • Stop Use

    Discontinue if skin irritation develops.

  • Keep Out Of Reach of Children.

    Keep out of reach of children.

  • Directions

    1. Clean and dry the affected areas before application.
    2. Remove the protective film while applying the areas 1-2 times daily, cut into smaller size if desired. If necessary up to 3 sheets per day.
    3. Use only as directed. Firmly affix with adhesive tapes or elastic bandages around joint areas to secure the patch if needed.

  • Storage

    Store at room temperature away from direct sunlight. Properly sealed to remain fresh.

  • Inactive Ingredients

    ANGELICA SINENSIS ROOT, ANGELICA DAHURICA WHOLE, ALMOND, SCROPHULARIA NINGPOENSIS ROOT, GLEDITSIA SINENSIS WHOLE, LIQUIDAMBAR FORMOSANA RESIN, ALLIUM FISTULOSUM WHOLE, TURPENTINE, FRANKINCENSE, MYRRH, YELLOW WAX, ROSIN, ZINC OXIDE, SESAME OIL

  • U.S. Sole Agent

    Finemost Corp., Qualiherb

    Cerritos, Ca 90703

    Tel:   (562)802-0035

    Fax: (562)802-0625

    Made in Taiwan

  • Drug Facts

    image description

  • INGREDIENTS AND APPEARANCE
    QUALI HERBAL 
    menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67536-882
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ANGELICA DAHURICA WHOLE (UNII: 667W6C5J4P)  
    ALMOND (UNII: 3Z252A2K9G)  
    SCROPHULARIA NINGPOENSIS ROOT (UNII: HC0FB6P85R)  
    GLEDITSIA SINENSIS WHOLE (UNII: FS3UB95UTG)  
    LIQUIDAMBAR FORMOSANA RESIN (UNII: 597LBL467J)  
    ALLIUM FISTULOSUM WHOLE (UNII: 51BV41D79A)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    MYRRH (UNII: JC71GJ1F3L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ROSIN (UNII: 88S87KL877)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67536-882-01100 in 1 BOX10/10/2013
    116 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/10/2013
    Labeler - Teh Seng Pharmaceutical Mfg. Co., Ltd (656347721)
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