Label: SHARK CARTILAGE 12C- shark cartilage liquid

  • NDC Code(s): 43857-0633-1
  • Packager: BioActive Nutritional, Inc.
  • 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 April 11, 2023

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  • ACTIVE INGREDIENTS:

    Shark Cartilage 12C.

  • PURPOSE:

    For temporary relief of painful lower back with burning, looseness of ligaments & general soreness, aching tendons, ligaments, and bones.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • INDICATIONS:

    For temporary relief of painful lower back with burning, looseness of ligaments & general soreness, aching tendons, ligaments, and bones.

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    SHARK CARTILAGE

                12C

    HOMEOPATHIC

    2 FL OZ (60 ml)

    SHARK CARTILAGE 12C

  • INGREDIENTS AND APPEARANCE
    SHARK CARTILAGE  12C
    shark cartilage liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0633
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SHARK CARTILAGE (UNII: D2YCN1I522) (SHARK CARTILAGE - UNII:D2YCN1I522) SHARK CARTILAGE12 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0633-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2023
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0633) , api manufacture(43857-0633) , label(43857-0633) , pack(43857-0633)
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