Label: CHITOPREX 101- 38 biotech laboratory llc capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 69573-888-11, 69573-888-33 - Packager: 38 Biotech Laboratory 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 February 27, 2015
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- Official Label (Printer Friendly)
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
CHITOPREX 101
38 biotech laboratory llc capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69573-888 Route of Administration NASAL, INTRATUMOR, IRRIGATION, INTRAVENOUS, ORAL, PERIODONTAL, INTRAOCULAR, RECTAL, SUBLINGUAL, TOPICAL, TRANSDERMAL, VAGINAL, URETERAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64) (CHITOSAN OLIGOSACCHARIDE - UNII:23R93M6Y64) CHITOSAN HIGH MOLECULAR WEIGHT (800-2000 MPA.S) 250 mg in 250 mg Inactive Ingredients Ingredient Name Strength Nori (UNII: 477TV3P5UX) 250 mg in 250 mg Product Characteristics Color brown (wet brown sugar like) Score score with uneven pieces Shape CAPSULE (400mg) Size 1mm Flavor CHICKEN Imprint Code 1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69573-888-33 30 in 1 BOTTLE 05/16/2015 1 NDC:69573-888-11 500 mg in 1 CAPSULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/27/2015 Labeler - 38 Biotech Laboratory LLC (079677339) Establishment Name Address ID/FEI Business Operations 38 Biotech Laboratory LLC 079677339 manufacture(69573-888)