Label: CHITOPREX 101- 38 biotech laboratory llc capsule

  • 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 February 27, 2015

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  • WARNINGS

    WARNINGS

  • DOSAGE & ADMINISTRATION

    DOSAGE & ADMINISTRATION

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

  • INDICATIONS & USAGE

    INDICATIONS & USE

  • PURPOSE

    OTC-PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    LABEL PRINCIPAL DISPLAY PANEL

  • ACTIVE INGREDIENT

    OTC-ACTIVE INGREDIENT

  • INGREDIENTS AND APPEARANCE
    CHITOPREX  101
    38 biotech laboratory llc capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69573-888
    Route of AdministrationNASAL, INTRATUMOR, IRRIGATION, INTRAVENOUS, ORAL, PERIODONTAL, INTRAOCULAR, RECTAL, SUBLINGUAL, TOPICAL, TRANSDERMAL, VAGINAL, URETERAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64) (CHITOSAN OLIGOSACCHARIDE - UNII:23R93M6Y64) CHITOSAN HIGH MOLECULAR WEIGHT (800-2000 MPA.S)250 mg  in 250 mg
    Inactive Ingredients
    Ingredient NameStrength
    Nori (UNII: 477TV3P5UX) 250 mg  in 250 mg
    Product Characteristics
    Colorbrown (wet brown sugar like) Scorescore with uneven pieces
    ShapeCAPSULE (400mg) Size1mm
    FlavorCHICKENImprint Code 1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69573-888-3330 in 1 BOTTLE05/16/2015
    1NDC:69573-888-11500 mg in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/27/2015
    Labeler - 38 Biotech Laboratory LLC (079677339)
    Establishment
    NameAddressID/FEIBusiness Operations
    38 Biotech Laboratory LLC079677339manufacture(69573-888)