Label: GOLD EDITION ULTRA ZHENG GU SHUI- menthol camphor liquid

  • 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 August 31, 2022

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  • Active ingredients

    Menthol 4.09%.................................External analgesic

    Camphor 4.09%.................……….…….External analgesic

  • ASK DOCTOR

    Do not use otherwise than as directed

  • Keep out of reach of children

    Keep out of reach of children to avoid accidental poisoning

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

  • If pregnant

    If pregnant, ask a health professional before use

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
    • Children under 12 years of age: Do not use or consult a doctor.
  • Other information

    store at room temperature, 20 o to 25 oC(68 o to 77 oF)

  • Inactive ingredients

    Aconitum kusnezoffii, Alocasia macrorrhiza,Angelica dahurica, Angelica pubescens,Ardisia crenata,Ardisia gigantifolia, Artocarpus styracifolius,Calophyllum membranaceum, Clematis chinensis, Cudrania cochinchinensis,Curcuma phaeocaulis,Cyathula officinalis,Cynanchum paniculatum, Ethanol,Eucommia ulmoides,Eupolyphaga sinensis,Kadsura coccinea,Millettia pulchra,Periploca sepium,Piper wallichii, Polygonum cuspidatum,Sarcandra glabra,Sparganium stoloniferum,Spatholobus suberectus

  • Questions?

    +1-888-915-6789

    M-F 9am to 5pm Pacific Time
    You may report serious side effects to this phone number.

  • Purpose

    External analgesic

  • Do not use

    • on wounds
    • 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 this product

    • avoid contact with the eyes or on mucous membranes
    • do not bandage tightly
    • do not apply to wounds or damaged skin
    • do not use 1 hour before or after bathing
  • 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
    • eexcessive irritation of the skin develops
    • redness is present
  • Warnings

    For external use only

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints due to:

    • arthritis
    • strains
    • bruises
    • sprains
    • simple backache
  • PDP

    Outer Package

  • INGREDIENTS AND APPEARANCE
    GOLD EDITION ULTRA ZHENG GU SHUI 
    menthol camphor liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59321-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4.09 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.09 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)  
    ALOCASIA MACRORRHIZOS WHOLE (UNII: P600HQ573H)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)  
    ARDISIA CRENATA ROOT (UNII: 74U2K67MND)  
    ARDISIA GIGANTIFOLIA WHOLE (UNII: WEC9M7UOAG)  
    ARTOCARPUS STYRACIFOLIUS ROOT (UNII: L1D54XX58F)  
    CALOPHYLLUM MEMBRANACEUM ROOT (UNII: 6G661AA4F2)  
    CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
    MACLURA COCHINCHINENSIS ROOT (UNII: 3WTU9E1VPU)  
    CURCUMA PHAEOCAULIS ROOT (UNII: P7PXC11S4S)  
    CYATHULA OFFICINALIS ROOT (UNII: BRM37UP34O)  
    CYNANCHUM PANICULATUM WHOLE (UNII: T14ONG8D7H)  
    ALCOHOL (UNII: 3K9958V90M)  
    EUCOMMIA ULMOIDES BARK (UNII: L878N1L0AR)  
    EUPOLYPHAGA SINENSIS (UNII: 7USH1LF92M)  
    KADSURA COCCINEA WHOLE (UNII: 81P4AE27JI)  
    MILLETTIA PULCHRA WHOLE (UNII: 861IW7ATEH)  
    PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)  
    PIPER WALLICHII LEAFY TWIG (UNII: IZT4A4E63F)  
    POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
    SARCANDRA GLABRA WHOLE (UNII: YI11034BNN)  
    SPARGANIUM STOLONIFERUM WHOLE (UNII: 873IV8AW3C)  
    SPATHOLOBUS SUBERECTUS STEM (UNII: N51VZ363BA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59321-011-881 in 1 BOX08/31/2022
    188 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/31/2022
    Labeler - Guangxi Yulin Pharmaceutical Group Co., Ltd. (653862581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangxi Yulin Pharmaceutical Group Co., Ltd.653862581manufacture(59321-011)
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