Label: BIO OAK- quercus alba bark liquid

  • NDC Code(s): 43857-0118-1
  • Packager: BioActive Nutritional, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/15

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

  • ACTIVE INGREDIENTS:

    Oak 6X, 30C, 200C

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  • INDICATIONS:

    For temporary relief of strength and courage with a need to fight against great odds, and never knowing when to let go of the fight.

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  • 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.

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  • DIRECTIONS:

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

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  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

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  • KEEP OUT OF REACH OF CHILDREN:

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

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  • INDICATIONS:

    For temporary relief of strength and courage with a need to fight against great odds, and never knowing when to let go of the fight.

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  • QUESTIONS:

    Distributed by:

    BIOACTIVE NUTRITIONAL

    Melbourne, FL 32935

    For Nutritional Information write:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

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  • PACKAGE LABEL DISPLAY:

    BioActive Homeopathic

    BIO OAK 6X, 30C, 200C

    1 FL OZ (30 ml)

    Bio Oak 6X, 30C, 200C

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  • INGREDIENTS AND APPEARANCE
    BIO OAK 
    oak liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0118
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    QUERCUS ALBA BARK (UNII: 93LP7Y8EGT) (QUERCUS ALBA BARK - UNII:93LP7Y8EGT) QUERCUS ALBA BARK 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43857-0118-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/30/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0118) , api manufacture(43857-0118) , label(43857-0118) , pack(43857-0118)
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