Label: ALLERGIES FRAGRANCES AND PHENOLICS- acetaldehyde, arsenicum album, balsamum peruvianum, calcarea carbonica, carbolicum acidum, conium maculatum, coumarinum, crocus sativus, histaminum hydrochloricum, lachesis mutus, lycopodium clavatum, phosphorus, sepia 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 January 31, 2017

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  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________________

    HPUS active ingredients: ​Acetaldehyde, Arsenicum album, Balsamum peruvianum, Calcarea carbonica, Carbolicum acidum, Conium maculatum, Coumarinum, Crocus sativus, Histaminum hydrochloricum, Lachesis mutus, Lycopodium clavatum, Phosphorus, Sepia. Equal volumes of each ingredient in 12X, 24X, 30C, 1LM, 2LM, 3LM, 5LM potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of symptoms from fragrances, spices & phenolics: respiratory irritations, irritation of skin, eyes and mucous membranes, headache, mild depression, lethargy, nausea, and mood swings.

  • INACTIVE INGREDIENT

    Inactive ingredients: Bio-Energetically Enhanced pure water, citric acid, 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.
    • Children 2-12- 2 sprays 3 times per day.
    • Children 2 mo.-2yr.- 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 temporary relief of symptoms from fragrances, spices & phenolics:

    • respiratory irritations
    • irritation of skin, eyes and mucous membranes
    • headache
    • mild depression
    • lethargy
    • nausea
    • mood swings
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGIES FRAGRANCES AND PHENOLICS 
    acetaldehyde, arsenicum album, balsamum peruvianum, calcarea carbonica, carbolicum acidum, conium maculatum, coumarinum, crocus sativus, histaminum hydrochloricum, lachesis mutus, lycopodium clavatum, phosphorus, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-2205
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETALDEHYDE (UNII: GO1N1ZPR3B) (ACETALDEHYDE - UNII:GO1N1ZPR3B) ACETALDEHYDE12 [hp_X]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 59 mL
    BALSAM PERU (UNII: 8P5F881OCY) (BALSAM PERU - UNII:8P5F881OCY) BALSAM PERU12 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 59 mL
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL12 [hp_X]  in 59 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP12 [hp_X]  in 59 mL
    COUMARIN (UNII: A4VZ22K1WT) (COUMARIN - UNII:A4VZ22K1WT) COUMARIN12 [hp_X]  in 59 mL
    SAFFRON (UNII: E849G4X5YJ) (SAFFRON - UNII:E849G4X5YJ) SAFFRON12 [hp_X]  in 59 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE12 [hp_X]  in 59 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [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:57955-2205-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/24/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-2205)
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