Label: SWOLLEN GLANDS RELIEF- astacus fluviatilis, baryta iodata, calcarea iodata, cistus canadensis, clematis erecta, conium maculatum, iodium, lacticum acidum, mercurius iodatus ruber, mercurius vivus, phytolacca decandra, scrophularia nodosa, spongia tosta liquid

  • 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 December 13, 2016

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Astacus fluviatilis, Baryta iodata, Calcarea iodata, Cistus canadensis, Clematis erecta, Conium maculatum, Iodium, Lacticum acidum, Mercurius iodatus ruber, Mercurius vivus, Phytolacca decandra, Scrophularia nodosa, Spongia tosta​. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.

  • INDICATIONS & USAGE

    Uses for fast relief of symptoms associated with viral inflammations such as colds and flu: enlarged, swollen and painful glands, inflamed glands of the neck, jaw, armpit, and groin.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults: 3 sprays 3 times per day.
    • ​Children 2-12 years: 2 sprays 3 times per day.
    • Children 2 mo-2 yr. 1 spray 3 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

  • PURPOSE

    Uses ​for fast relief of symptoms associated with viral inflammations such as colds and flu:

    • enlarged swollen and painful glands
    • inflamed glands of the neck, jaw, armpit, and groin
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SWOLLEN GLANDS RELIEF 
    astacus fluviatilis, baryta iodata, calcarea iodata, cistus canadensis, clematis erecta, conium maculatum, iodium, lacticum acidum, mercurius iodatus ruber, mercurius vivus, phytolacca decandra, scrophularia nodosa, spongia tosta liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0121
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASTACUS ASTACUS (UNII: V0551986XQ) (ASTACUS ASTACUS - UNII:V0551986XQ) ASTACUS ASTACUS10 [hp_X]  in 59 mL
    BARIUM IODIDE (UNII: WKC4T7680A) (BARIUM CATION - UNII:V645272HLN) BARIUM IODIDE10 [hp_X]  in 59 mL
    CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE10 [hp_X]  in 59 mL
    HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3) HELIANTHEMUM CANADENSE10 [hp_X]  in 59 mL
    CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP10 [hp_X]  in 59 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP10 [hp_X]  in 59 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE10 [hp_X]  in 59 mL
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4) (LACTIC ACID, DL- - UNII:3B8D35Y7S4) LACTIC ACID, DL-10 [hp_X]  in 59 mL
    MERCURIC IODIDE (UNII: R03O05RB0P) (MERCURIC IODIDE - UNII:R03O05RB0P) MERCURIC IODIDE10 [hp_X]  in 59 mL
    MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY10 [hp_X]  in 59 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT10 [hp_X]  in 59 mL
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA - UNII:7H443NUB2T) SCROPHULARIA NODOSA10 [hp_X]  in 59 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0121-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/29/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/21/2015
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0121)
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