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

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 19, 2023

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

  • 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)