Label: ZHONG HUA JIU PATCH- 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 March 5, 2013

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

  • ACTIVE INGREDIENTS

    MENTHOL 1%

  • PURPOSE

    EXTERNAL ANALGESIC

    FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS DUE TO: ARTHRITIS, STAINS, BRUISES, SPRAINS, SIMPLE BACKACHE.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

  • DO NOT USE

    ON WOUNDS, IRRITATED OR DAMAGED SKIN, SENSITIVE SKIN

  • WHEN USING THIS PRODUCT

    AVOID CONTACT WITH THE EYES

    DO NOT BANDAGE TIGHTLY

    DO NOT APPLY TO WOUNDS OR DAMAGED SKIN

    DO NOT USE ONE HOUR BEFORE OR AFTER BATHING

  • STOP USE AND ASK A DOCTOR IF

    CONDITION WORSENS

    SYMPTONS PERSIST FOR MORE THAN SEVEN DAYS

    SYMPTONS CLEAR UP AND OCCUR AGAIN WITH A FEW DAYS

    EXCESSIVE IRRITATION OF THE SKIN OR BURN DEVELOPS

    REDNESS IS PRESENT

  • PREGNANCY OR BREAST FEEDING

    IF PREGNANT, ASK A HEALTH PROFESSIONAL BEFORE USE

    DO NOT USE OTHERWISE AS DIRECTED

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL POISONING

  • DIRECTIONS

    ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: REMOVE PATCH FROM THE PROTECTIVE LAYER, APPLY TO THE AFFECTED AREA, AND RUB THE AREA WITH YOUR HAND TO SECURE THE PATCH.

    PATCH WILL REMAIN EFFECTIVE FOR 12 HOURS AND WILL BE MROE EFFECTIVE WHEN USED 1 HOUR AFTER BATHING.

    DO NOT LEAVE THE PATCH ON THE SAME SPOT FOR MORE THAN 12 HOURS.

    DO NOT APPLY TO THE AREA WITH EXCESSIVE HAIR. ADHESIVE PATCH MAY HURT SKIN UPON REMOVAL.

    CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE OR CONSULT A DOCTOR.

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE 20-25 DEGREES CENTIGRADE (68-77 DEGREES FAHRENHEIT)

  • INACTIVE INGREDIENTS

    ACTIVATED CHARCOL

    ANGELICA BISERRATA ROOT

    ARTEMISIA ARGYI LEAF

    BOSWELLIA SACRA BARK

    IRON

    2,4-D SODIUM SALT

    WATER

  • Questions or comments?

    Please call (626)285-1600 9:00 am - 5:30 pm PST

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    ZHONG HUA JIU PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53614-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) 110.3 mg  in 1000 mg
    ANGELICA BISERRATA ROOT (UNII: OJ90180B22) 3 mg  in 1000 mg
    ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ) 15.4 mg  in 1000 mg
    BOSWELLIA SACRA BARK (UNII: 1UK28DX728) 0.5 mg  in 1000 mg
    IRON (UNII: E1UOL152H7) 683.1 mg  in 1000 mg
    2,4-D SODIUM SALT (UNII: 2H005922RS) 11 mg  in 1000 mg
    WATER (UNII: 059QF0KO0R) 166.7 mg  in 1000 mg
    Product Characteristics
    Color    Score2 pieces
    ShapeRECTANGLESize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53614-001-021000 mg in 1 PATCH
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/15/2003
    Labeler - Wuhan Chinese Moxibustion Technology Development Co.; Ltd. (530590157)
    Registrant - Wuhan Chinese Moxibustion Technology Development Co.; Ltd. (530590157)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wuhan Chinese Moxibustion Technology Development Co.; Ltd.530590157manufacture(53614-001)