Label: ROTOSXIKA PROSTATE PATCH- adrenal gland, chelidonium majus, menthol patch

  • NDC Code(s): 83702-019-11, 83702-019-12
  • 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 18, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient: Adrenal gland 1g/100g, Chelidonium majus 1g/100g, Menthol 5g/100g

  • PURPOSE

    Purpose: Prostate pain

  • INDICATIONS & USAGE

    Use to:

    Temporarily alleviate the following symptoms: pain in the spermatic cord, testicles, liver, and prostate.

  • DOSAGE & ADMINISTRATION

    Directions
    Usage and dosage:External use. Open the packaging, remove the backing paper, and apply it to the Shenque acupoint (navel) and Shenshu acupoints every 6-8 hours per day.

  • WARNINGS

    Precautions
    1.This product is an external product, do not take it internally;
    2.This product is a health care product and does not replace drugs and medical devices fortreatment;
    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: 25% Ethanol

  • STATEMENT OF IDENTITY

    Other information:

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

    Produced by:

    Nanyang Jingzhilan Biotechnology Co., Ltd

    No.6,Road2,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

    Prostate PatchLabel

  • INGREDIENTS AND APPEARANCE
    ROTOSXIKA PROSTATE PATCH 
    adrenal gland, chelidonium majus, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83702-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN ADRENAL GLAND (UNII: B9LA98E55K) (HUMAN ADRENAL GLAND - UNII:B9LA98E55K) HUMAN ADRENAL GLAND1 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83702-019-128 in 1 BAG06/01/2023
    1NDC:83702-019-112.1 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(83702-019) , label(83702-019)
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