Label: RHEUMATIC TONIC I- ginkgo biloba, dioscorea villosa, glycyrrhiza glabra, viscum album, pinus sylvestris, apis mellifica, dulcamara, kalmia latifolia, lycopodium clavatum, sulphur liquid

  • NDC Code(s): 43857-0382-1
  • 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 July 20, 2018

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  • ACTIVE INGREDIENTS:

    Ginkgo Biloba 1X, Dioscorea Villosa 1X, Glycyrrhiza Glabra 3X, Viscum Album 3X, Pinus Sylvestris 6X, Apis Mellifica 12X, Dulcamara 12X, Kalmia Latifolia 12X, Lycopodium Clavatum 12X, Sulphur 12X.

  • INDICATIONS:

    For temporary relief of symptoms due to joint aches, pains, swelling, and rheumatism.

  • 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:

    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.

  • INDICATIONS:

    For temporary relief of symptoms due to joint aches, pains, swelling, and rheumatism.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25 Ethanol

  • QUESTIONS:

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

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional
    RHEUMATIC TONIC I
    HOMEOPATHIC
    2 FL OZ (60 ml)

    Rheumatic Tonic I

  • INGREDIENTS AND APPEARANCE
    RHEUMATIC TONIC  I
    ginkgo biloba, dioscorea villosa, glycyrrhiza glabra, viscum album, pinus sylvestris, apis mellifica, dulcamara, kalmia latifolia, lycopodium clavatum, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0382
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO1 [hp_X]  in 1 mL
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA TUBER1 [hp_X]  in 1 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA3 [hp_X]  in 1 mL
    VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP3 [hp_X]  in 1 mL
    PINUS SYLVESTRIS LEAFY TWIG (UNII: Q1RGP4UB73) (PINUS SYLVESTRIS LEAFY TWIG - UNII:Q1RGP4UB73) PINUS SYLVESTRIS LEAFY TWIG6 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP12 [hp_X]  in 1 mL
    KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18) KALMIA LATIFOLIA LEAF12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0382-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/11/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/11/2015
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0382) , api manufacture(43857-0382, 43857-0382, 43857-0382)
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