Label: RESERVED- aesculus carnea, flos, aloe socotrina, euphorbium officinarum, fagus sylvatica, flos, gelsemium sempervirens, hypericum perforatum, juglans regia, flos, kali muriaticum, magnesia muriatica, millefolium, muriaticum acidum, natrum carbonicum, phosphoricum acidum, plumbum metallicum, sepia, spongia tosta, stannum metallicum, theridion 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 June 23, 2014

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

  • ACTIVE INGREDIENT

    Drug Facts

    ___________________________________________________________________________________________________________

    HPUS active ingredients: Aesculus carnea, flos, Aloe socotrina, Euphorbium officinarum, Fagus sylvatica, flos, Gelsemium sempervirens, Hypericum perforatum, Juglans regia, flos, Kali muriaticum, Magnesia muriatica, Millefolium, Muriaticum acidum, Natrum carbonicum, Phosphoricum acidum, Plumbum metallicum, Sepia, Spongia tosta, Stannum metallicum, Theridion. Equal volumes of each ingredient in 10X, 30X, 100X, LM1, LM2, LM3, LM5 potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of: introversion, mild and reserved disposition, sensitivity to noise, sensory overload, tendency to avoid social interaction, verbal timidity.

  • INACTIVE INGREDIENT

    Inactive ingredients: Bio-Energetically Enhanced™ pure water, citric acid, potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask a doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare prodessional.
  • 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.
    • 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:

    • introversion
    • mild and reserved disposition
    • sensitivity to noise
    • sensory overload
    • tendency to avoid social interaction
    • verbal timidity
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RESERVED 
    aesculus carnea, flos, aloe socotrina, euphorbium officinarum, fagus sylvatica, flos, gelsemium sempervirens, hypericum perforatum, juglans regia, flos, kali muriaticum, magnesia muriatica, millefolium, muriaticum acidum, natrum carbonicum, phosphoricum acidum, plumbum metallicum, sepia, spongia tosta, stannum metallicum, theridion liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-2282
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AESCULUS CARNEA FLOWER (UNII: 717DPT98VM) (AESCULUS CARNEA FLOWER - UNII:717DPT98VM) AESCULUS CARNEA FLOWER10 [hp_X]  in 59 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE10 [hp_X]  in 59 mL
    EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN10 [hp_X]  in 59 mL
    FAGUS SYLVATICA FLOWERING TOP (UNII: 21AF0IHY5U) (FAGUS SYLVATICA FLOWERING TOP - UNII:21AF0IHY5U) FAGUS SYLVATICA FLOWERING TOP10 [hp_X]  in 59 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM10 [hp_X]  in 59 mL
    JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG) (JUGLANS REGIA FLOWERING TOP - UNII:3BA2N709NG) JUGLANS REGIA FLOWERING TOP10 [hp_X]  in 59 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION10 [hp_X]  in 59 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION10 [hp_X]  in 59 mL
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM10 [hp_X]  in 59 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB) HYDROCHLORIC ACID10 [hp_X]  in 59 mL
    SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE10 [hp_X]  in 59 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID10 [hp_X]  in 59 mL
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD10 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [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
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN10 [hp_X]  in 59 mL
    THERIDION CURASSAVICUM (UNII: 9Z8D3HEM8L) (THERIDION CURASSAVICUM - UNII:9Z8D3HEM8L) THERIDION CURASSAVICUM10 [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:57955-2282-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/23/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-2282)