Label: BREAST INFLAMMATIONS AND DISCOMFORTS- aconitum napellus, bellis perennis, bromium, bryonia, chamomilla, conium maculatum, iodium, phellandrium aquaticum, phytolacca decandra, scrophularia nodosa and 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 October 16, 2012

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  • Active Ingredients

    Official HPUS: Aconitum napellus, Bellis perennis, Bromium, Bryonia, Chamomilla, Conium maculatum, Iodium, Phellandrium aquaticum, Phytolacca decandra, Scrophularia nodosa and Silicea.

  • Inactive Ingredient



    Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X and LM1 potencies.

  • Purpose

    Uses a natural aid for breast discomfort:

    • Inflammation
    • mastitis
    • tenderness
    • hardness
    • soreness
    • chapped or irritated nipples from nursing
  • Dosage and Administration

    Directions Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed.

    Adult Dose 3 pump sprays

    Children 2-12 years 2 pump sprays

  • Warnings

    If symptoms persist or worsen, consult a physician. If pregnant or nursing, take only on advice of healthcare professional. Keep out of reach of children.

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Indications and Usage

    Uses a natural aid for breast discomfort: inflammation, mastitis, tenderness, hardness, soreness, chapped or irritated nipples from nursing.

  • PRINCIPAL DISPLAY PANEL


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    King Bio Inc.

    3 Westside Drive

    Asheville, NC 28806

    Questions? Call 800.543.3245

    www.kingbio.com

  • INGREDIENTS AND APPEARANCE
    BREAST INFLAMMATIONS AND DISCOMFORTS 
    aconitum napellus, bellis perennis, bromium, bryonia, chamomilla, conium maculatum, iodium, phellandrium aquaticum, phytolacca decandra, scrophularia nodosa and silicea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-5003
    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
    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) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
    OENANTHE AQUATICA FRUIT (UNII: N4LEE4Z93J) (OENANTHE AQUATICA FRUIT - UNII:N4LEE4Z93J) OENANTHE AQUATICA FRUIT10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-5003-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/19/2012
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-5003)
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