Label: BREAST CYST AND DISCOMFORTS- aconitum napellus, bellis perennis, bromium, bryonia, chamomilla, conium maculatum, iodium, phellandrium aquaticum, phytolacca decandra, scrophularia nodosa, silicea 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 April 17, 2014

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Aconitum napellus, Bellis perennis, Bromium, Bryonia, Chamomilla, Conium maculatum, Iodium, Phellandrium aquaticum, Phytolacca decandra, Scrophularia nodosa, Silicea​​​. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing.

  • 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: 12 and up: 3 sprays 3 times per day.
    • Use additionally as needed, up to 6 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact.

  • PURPOSE

    Uses for temporary relief of symptoms: 

    • inflammation
    • tenderness
    • lumpiness
    • hardness
    • soreness
    • cracked or irritated nipples from nursing
    • shrinking breasts following nursing
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BREAST CYST AND DISCOMFORTS 
    aconitum napellus, bellis perennis, bromium, bryonia, chamomilla, conium maculatum, iodium, phellandrium aquaticum, phytolacca decandra, scrophularia nodosa, silicea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS10 [hp_X]  in 59 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS10 [hp_X]  in 59 mL
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE10 [hp_X]  in 59 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [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
    OENANTHE AQUATICA FRUIT (UNII: N4LEE4Z93J) (OENANTHE AQUATICA FRUIT - UNII:N4LEE4Z93J) OENANTHE AQUATICA FRUIT10 [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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0003-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/17/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0003)
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