Label: IXERIS DENTICULATA- crepidiastrum sonchifolium whole powder

  • NDC Code(s): 83494-001-01
  • Packager: Oriental Yutai Health Management LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 26, 2023

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  • Active ingredients

    Lactuca indica

  • Purpose

    Unclog the whole body and improve sleep

  • Indications & usage section

    Sleep disorders, insomnia， direct oral administration

  • Warnings

    Ask a Health professionals before use if you have

    ■This product is a health food of the same origin of medicine and food. It should not be overused. The elderly and children should take it under the supervision of adults. If you are pregnant or breastfeeding, please consult health professionals before use.

  • Keep out of reach for children.

    Keep out of reach for children.

  • When using this product

    Consult a professional health manager in time if you have adverstions.
    If pregnant or breast-feeding, ask a health professional before use.

  • Directions

    adults and children 12 years and over Three meals a day once in the morning, once in the middle of the evening, one bag at a time, rinse with warm water, no more than four bags per day, according to the professional health counsellor, take it according to the course of treatment.
    children 6 years to under 12 years Consult a professional health engineer
    children under 6 years Consult a professional health engineer

  • Inactive ingredients

    CHIA SEED、SENNA OBTUSIFOLIA SEED

  • PRINCIPAL DISPLAY PANEL

    001

  • INGREDIENTS AND APPEARANCE
    IXERIS DENTICULATA 
    crepidiastrum sonchifolium whole powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83494-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CREPIDIASTRUM SONCHIFOLIUM WHOLE (UNII: HF9V17322F) (CREPIDIASTRUM SONCHIFOLIUM WHOLE - UNII:HF9V17322F) CREPIDIASTRUM SONCHIFOLIUM WHOLE80 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHIA SEED (UNII: NU0OLX06F8)  
    SENNA OBTUSIFOLIA SEED (UNII: 916A1U7U6S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83494-001-0118 in 1 BOX05/26/2023
    19 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/26/2023
    Labeler - Oriental Yutai Health Management LLC (118993116)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oriental Yutai Health Management LLC118993116manufacture(83494-001)
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