Label: ROTOSXIKA TINNITUS RELIEF PATCH- menthol patch

  • NDC Code(s): 83702-018-11, 83702-018-12
  • Packager: Puning Xinhua Trade Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 19, 2023

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  • ACTIVE INGREDIENT

    Active ingredient: Menthol 5g/100g

  • PURPOSE

    Purpose: Relieve tinnitus

  • INDICATIONS & USAGE

    Indication:

    Helps alleviate symptoms of tinnitus.

  • DOSAGE & ADMINISTRATION

    Directions:

    For external use,remove the antisticking paper,apply the plaster to the Yongquan point on the feet or behind the ears for 8-12 hours each time.

  • WARNINGS

    Precautions

    1.This product is an external product, do not take it internally;

    2.This product is a health careproduct and does not replace drugs and medical devices for treatment;

    3.Pregnant women, infants, breastfeeding, and those allergic to this product are prohibited;

    4.Do not use skin allergies, skin damage, skin diseases and other symptoms;

    5.If the skin appears red, itchy and other abnormal conditions during use, please suspend use.

  • QUESTIONS

    Questions or comments? +8617846992567

  • INACTIVE INGREDIENT

    Inactive Ingredients: Frankincense myrrh.

  • STATEMENT OF IDENTITY

    Other information:

    Sealed packaging, please keep in a cool and dark place.

    Produced by:
    Nanyang Jingzhilan Biotechnology Co.,Ltd
    No.6,Road 2,Longsheng Industrial Park,Wangcun Township, Wolong District,Nanyang City
    OEM Company: Puning Xinhua Trade Co.,Ltd

    Made in China

  • KEEP OUT OF REACH OF CHILDREN

    Same as WARNINGS SECTION

  • PRINCIPAL DISPLAY PANEL

    Label Tinnitus Relief Patch

  • INGREDIENTS AND APPEARANCE
    ROTOSXIKA TINNITUS RELIEF PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83702-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    MYRRH (UNII: JC71GJ1F3L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83702-018-1212 in 1 BAG06/01/2023
    1NDC:83702-018-112.1 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2023
    Labeler - Puning Xinhua Trade Co., Ltd. (632673277)
    Registrant - Nanyang Jingzhilan Biotechnology Co., Ltd. (724044399)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanyang Jingzhilan Biotechnology Co., Ltd.724044399manufacture(83702-018) , label(83702-018)
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