Label: YAN JI HUO JIN TOU GU GAO- menthol 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 January 22, 2018

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

  • ​Drug Facts

  • ​Active ingredients

    Menthol 4%

  • Purpose

    Topical Analgesic

  • ​Uses

    Temporary relief minor aches and pains of muscles and joints associated with:

    • Arthritis • Bruises • Simple backache • Strains • Sprains

  • ​Warnings:

    For external use only

    ​When using this product

    • use only as directed

    • avoid contact with eyes, mucous membranes or rashes

    • do not apply to broken, wounded or damaged skin

    • do not bandage or cover with any type of wrap except clothing

    • do not use with a heating pad or apply external heat

    • discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower

    ​Stop use and ask a doctor if

    • rash, itching or excessive skin irritation develops

    • condition worsens or does not improve after regular use

    • symptoms persist for more than 7 days or clear up and occur again within a few days

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • ​Directions:

    ​Adult and children over 12 years of age:

    • clean and dry affected area

    • open pouch and remove patch, if desired, cut patch to size

    • peel off protective backing and apply sticky side to affected area

    • apply to affected area not more than 3 times daily

    • remove patch from the skin before a maximum 8 hours application.

    ​Children under 12 years of age

    • consult a doctor before use​​​

  • ​Inactive ingredients:

    Clematis Chinensis Root, Momordica Cochinchinensis Seed, Ricinus Communis Seed, Myrrh, Frankincense, Rosin, Yellow Wax, Zinc Oxide, Methyl Salicylate, FD&C Yellow #5 (a colorant), Indigo Carmine (a colorant), Sesame Oil

  • ​Other information:

    • This product may cause allergic reaction in some individuals.

    • store in cool dry place and avoid direct sunlight

    • keep patches tightly closed in the zip lock bag

  • SPL UNCLASSIFIED SECTION

    EXTERNAL PAIN RELIEVING PATCH

    Elastic Patch

    HERBAL PATCH

    Product of Taiwan

    US Distributor:

    MAXAM, Hayward, CA 94545

    MAXAM, PO Box 888, Newark, CA 94560

    email:maxambition@yahoo.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    YAN JI HUO JIN TOU GU GAO 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72183-769
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
    MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    MYRRH (UNII: JC71GJ1F3L)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    ROSIN (UNII: 88S87KL877)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72183-769-235 in 1 BAG06/28/2018
    11.0 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/28/2018
    Labeler - MAXAM (081104925)