Label: COTTON PIECE- chitosan cloth

  • 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 August 4, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient(s)

    Chitosan 0.01g in 1000g

  • Purpose

    Antiseptic

  • Use

    For skin cleaning.

  • Warnings

    For external use only. It is not allowed for people who are allergic to this product.

  • STOP USE

    If you find skin swelling and inflammation, stop using it immediately and consult your doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Children should be used under adult supervision to avoid accidental ingestion.

  • Directions

    Open it and use it.

  • Other information

    Keep away from light and sealed.

  • Inactive ingredients

    Water, Non-woven fabric

  • Package Label - Principal Display Panel

    label-40 wipes

  • INGREDIENTS AND APPEARANCE
    COTTON PIECE 
    chitosan cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90059-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLIGLUSAM (UNII: 82LKS4QV2Y) (POLIGLUSAM - UNII:82LKS4QV2Y) POLIGLUSAM0.01 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90059-002-01240 g in 1 BAG; Type 0: Not a Combination Product08/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/05/2020
    Labeler - Qingdao Miuton Medical Co.,LTD. (544362883)
    Registrant - Qingdao Miuton Medical Co.,LTD. (544362883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qingdao Miuton Medical Co.,LTD.544362883manufacture(90059-002)