Label: SHIZHENTAIYITANG MOXIBUSTION PATCH- chinese medicine patch tape

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 13, 2022

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

  • Active ingredient

    butylene glycol 20%) w/w (0.2g/package)

  • Inactive ingredient

    water

    hydroxyethylcellulose

    polyethylene glycol 300000

    phenoxyethanol

    chlorphenesin

  • Purpose

    It is a heat disposable paster incorporating chemicals that provides heat therapy for body.

  • When using

    Conditioning neck, back, hands and feet and other rheumatism pain and spleen and stomach caused by cold injury, deficiency diarrhea and other conditions.

  • Do not use

    If irritation or discomfort occurs, discontinue the use and consult a physician.

  • Stop use

    If irritation or discomfort occurs, discontinue the use and consult a physician.

  • Ask doctor

    If irritation or discomfort occurs, discontinue the use and consult a physician.

  • Ask doctor/pharmacist

    Ask doctor/pharmacist when you current use other drugs.

  • Keep out of reach of children

    Keep out of reach of children and away from eyes and ears.

  • Questions

    Please contact us when you have any questions.

  • Pregnancy or breast feeding

    Pregnant or breast feeding women shall follow doctor advice.

  • Indications & usage

    Pain relief, hot release, warming uterus, hemostatic, can be used to improve the conditioning neck, back, hands and feet and other rheumatism pain and spleen and stomach caused by cold injury, deficiency diarrhea and other conditions.

    Apply one paster on stomach venter.

  • Dosage & administration

    One time one patch.

  • Dosage forms & strengths

    Its dosage form is patch.

    A patch one time, or reapply as needed.

    One gram in one patch.

    The active ingredient strength is 20% w/w.

  • Warnings

    If irritation or discomfort occurs, discontinue the use and consult a physician.

    Very slippery on surfaces, clean spills immediately.

    Keep out of reach of children and pets.

  • Package label. Principal display panel

    Box labelContainer labelPackage labelInstructionsNew LabelingNew Package

  • INGREDIENTS AND APPEARANCE
    SHIZHENTAIYITANG MOXIBUSTION PATCH 
    chinese medicine patch tape
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72624-526
    Route of AdministrationCUTANEOUS, EXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA) BUTYLENE GLYCOL0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYETHYLENE GLYCOL 300000 (UNII: 4QIB4U4CQR)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72624-526-062 in 1 BOX10/13/2022
    1NDC:72624-526-033 in 1 BAG
    1NDC:72624-526-011 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/13/2022
    Labeler - Hubei Lishizhen Modern Biological Medicine Group Co.,Ltd. (421166905)
    Registrant - Hubei Lishizhen Modern Biological Medicine Group Co.,Ltd. (421166905)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hubei Lishizhen Modern Biological Medicine Group Co.,Ltd.421166905label(72624-526) , manufacture(72624-526)