QUALI WARM (MENTHOL, METHYL SALICYLATE) PATCH [TEH SENG PHARMACEUTICAL MFG. CO., LTD]

QUALI WARM (MENTHOL, METHYL SALICYLATE) PATCH [TEH SENG PHARMACEUTICAL MFG. CO., LTD]
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NDC 67536-883-01
Set ID bf4dd60f-3423-4693-8418-85e7b1577c89
Category HUMAN OTC DRUG LABEL
Packager Teh Seng Pharmaceutical Mfg. Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENTS

    Menthol  3.0%

    Methyl Salicylate  0.8%

  • 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

    Ginger, Gelatin, Frankincense, Myrrh, Rosin, Turpentine, Zinc Oxide

  • 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 WARM 
    menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67536-883
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GINGER (UNII: C5529G5JPQ)  
    GELATIN (UNII: 2G86QN327L)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    MYRRH (UNII: JC71GJ1F3L)  
    ROSIN (UNII: 88S87KL877)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67536-883-01100 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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