Label: ULTRA STRENGTH ZHENG GU SHUI- menthol and camphor liniment

  • NDC Code(s): 59321-056-02
  • Packager: GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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  • ACTIVE INGREDIENT

    Active ingredient
    Menthol 4.1%
    Camphor 4.1%

  • PURPOSE

    Purpose
    External analgesic
    External analgesic

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains of muscles and joints due to:
    ■ arthritis
    ■ strains
    ■ bruises
    ■ sprains
    ■ simple backache

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use
    ■ on wounds
    ■ on irritated or damaged skin
    ■ sensitive skin
    ■ with a heating pad
    ■ if pregnant
    ■ with, or at the same time as, other external analgesic products
    ■ if allergic to any ingredients of this product

  • WHEN USING

    When using this product
    ■ avoid contact with the eyes or mucous membranes

    ■ do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if
    ■ condition worsens

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

    ■ excessive irritation of the skin develops

    ■ redness is present

  • PREGNANCY OR BREAST FEEDING

    If pregnant, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning.

    If swallowed, get medical hep or contact a Poison Control Center right away.

    Do not use otherwise than as directed.

  • ADVERSE REACTIONS

    Report any unexpected side effects from the use of this product to the FDA MedWatch Program.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    ■ Children under 2 years of age: do no use or consult a doctor.

  • STORAGE AND HANDLING

    Other information
    ■ store at room temperature, 20 to 25 C (68 to 77 F)

  • INACTIVE INGREDIENT

    Inactive ingredients Alcohol, angelica dahurice root, angelica pubescens root, ardisia crenata root, ardisia gigantifolia root, artocarpus styracifolius root, calophyllum membranaceum whole, clematis chinensis root, curcuma phaeocaulis root, cyathulae officinalis root, cynanchum paniculatum root, eucommia ulmoides bark, kadsura coccinea whole, lasiobema championii stem, maclura cochinensis root, millettia pulchra root, periploca sepium root bark, piper hancei top, pothos repens root, reynoutria japonica root, sarcandra glabra top, securidaca inappendiculata root, spargnaium stoloniferum root, and spatholobus suberectus stem.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
    ■ You may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    ULTRA STRENGTH ZHENG GU SHUI

    MENTHOL AND CAMPHOR

    NDC 59321-056-02

    EXTERNAL ANALGESIC

    3.0 FL OZ (88 ML)

    IMAGE OF CARTONIMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH ZHENG GU SHUI 
    menthol and camphor liniment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59321-056
    Route of AdministrationPERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.1 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)  
    ARDISIA CRENATA ROOT (UNII: 74U2K67MND)  
    ARDISIA GIGANTIFOLIA ROOT (UNII: 0E347O3NMS)  
    ARTOCARPUS STYRACIFOLIUS ROOT (UNII: L1D54XX58F)  
    CALOPHYLLUM MEMBRANACEUM WHOLE (UNII: M8FV4OUJ6F)  
    CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
    CURCUMA PHAEOCAULIS ROOT (UNII: P7PXC11S4S)  
    CYATHULA OFFICINALIS ROOT (UNII: BRM37UP34O)  
    CYNANCHUM PANICULATUM ROOT (UNII: CZP7EPR012)  
    EUCOMMIA ULMOIDES BARK (UNII: L878N1L0AR)  
    KADSURA COCCINEA WHOLE (UNII: 81P4AE27JI)  
    LASIOBEMA CHAMPIONII STEM (UNII: U33KT97I2D)  
    MACLURA COCHINCHINENSIS ROOT (UNII: 3WTU9E1VPU)  
    MILLETTIA PULCHRA ROOT (UNII: TBW2M73EBN)  
    PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)  
    PIPER HANCEI TOP (UNII: AMU868N7QW)  
    POTHOS REPENS ROOT (UNII: L3VA8YE43K)  
    REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)  
    SARCANDRA GLABRA TOP (UNII: 32E1WPH24S)  
    SECURIDACA INAPPENDICULATA ROOT (UNII: 0SVU07NNEC)  
    SPARGANIUM STOLONIFERUM ROOT (UNII: 66ZQ85S65H)  
    SPATHOLOBUS SUBERECTUS STEM (UNII: N51VZ363BA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59321-056-021 in 1 BOX04/04/2023
    188 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugpart34804/04/2023
    Labeler - GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD (653862581)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD653862581manufacture(59321-056)
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