Label: ZHENG GU SHUI- camphor, menthol liniment

  • NDC Code(s): 59321-055-01, 59321-055-02, 59321-055-03, 59321-055-04, view more
    59321-055-05
  • Packager: GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD
  • 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 December 13, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients
    Camphor 5.6%
    Menthol 5.6%

  • PURPOSE

    Purpose
    External Analgesic
    External Analgesic

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings
    For external use only

    Flammable
    Keep away from fire or flame

  • WHEN USING

    When using this product
    avoid contact with the eyes and 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 develops
    nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    when using for pain of arthritis:
    pain persists for more than 10 days
    redness is present
    in conditions affecting children under 12 years of age

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 not use, consult a doctor.

  • STORAGE AND HANDLING

    Other Information
    keep container tightly closed
    store at room temperature under 86°F (30°C)

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Alcohol, Japanese knotweed (Polygonum cuspidatum Siebold & Zucc.) rhizome, paniculate swallowwort [Pycnostelma paniculatum (Bge.) K. Schum.] root, shin-leaf prickly ash [Zanthoxylum nitidum (Roxb.) DC.] root, water, zedoary rhizome.

  • QUESTIONS

    Questions or Comments? (888) 221-3496 M-F 9 am to 5 pm

  • PRINCIPAL DISPLAY PANEL

    ZHENG GU SHUI

    NDC 59321-055-01

    EXTERNAL ANALGESIC LOTION

    3.4 FL OZ (100 mL)
    Box1

  • INGREDIENTS AND APPEARANCE
    ZHENG GU SHUI 
    camphor, menthol liniment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59321-055
    Route of AdministrationPERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.6 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYGONUM CUSPIDATUM WHOLE (UNII: 1VDG5Y5HS6)  
    CYNANCHUM PANICULATUM ROOT (UNII: CZP7EPR012)  
    ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)  
    WATER (UNII: 059QF0KO0R)  
    ZEDOARY (UNII: 123C43G128)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59321-055-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/19/2000
    2NDC:59321-055-0288 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/19/2000
    3NDC:59321-055-0360 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/2000
    4NDC:59321-055-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product10/19/2000
    5NDC:59321-055-0512 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/19/2000
    Labeler - GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD (653862581)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD653862581manufacture(59321-055)
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