Label: STYE SYMPTOM FORMULA- apis mellifica, calcarea picrata, graphites, hepar sulphuris calcareum, juglans regia, lycopodium clavatum, pulsatilla, silicea, staphysagria, sulfur, thuja occidentalis 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 8, 2014

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

  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    HPUS active ingredients: Apis mellifica, Calcarea picrata, graphites, Hepar sulphuris calcareum, Juglans regia, Lycopodium clavatum, Pulsatilla, Silicea, Staphysagria, Sulphur, Thuja occidentalis.

  • INDICATIONS & USAGE

    Uses for temporary relief from symptoms of styes or hordeolums:

    • swollen eyelids
    • eyelid discomfort
    • redness
    • sensitivity to touch
    • inflammation
    • itching
    • stinging
  • WARNINGS

    Warnings

    • Do not use in eyes - oral use only
    • Stop use and ask a doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, ask a healthcare professional before use.
  • 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 ages 2-12: 2 sprays 3 times per day.
    • Use additionally as needed, up to 6 times per day.
  • OTHER SAFETY INFORMATION

    Other Information

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

    Inactive Ingredients: Citric acid, potassium sorbate, purified water.

  • PURPOSE

    Drug Facts

    __________________________________________________________________________________________________________________

    HPUS active ingredients                                                                    Purpose

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    Apis mellifica.............................................................................styes, stinging

    Calcarea picrata.........................................................................boils

    Graphites..................................................................................red, swollen, and dry eyelids

    Hepar sulphuris calcareum..........................................................eye discomfort

    Juglans regia.............................................................................small, red eruptions

    Lycopodium clavatum.................................................................ulceration of eyelids

    Pulsatilla...................................................................................itching

    Silicea......................................................................................eyes tender to touch

    Staphysagria.............................................................................recurrent styes, eye discomfort

    Sulphur....................................................................................heat in eyes

    Thuja occidentalis......................................................................dry and scaly eyelids

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    STYE SYMPTOM FORMULA 
    apis mellifica, calcarea picrata, graphites, hepar sulphuris calcareum, juglans regia, lycopodium clavatum, pulsatilla, silicea, staphysagria, sulfur, thuja occidentalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-7225
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]  in 29.6 mL
    CALCIUM PICRATE (UNII: 53D441QVT8) (CALCIUM PICRATE - UNII:53D441QVT8) CALCIUM PICRATE10 [hp_X]  in 29.6 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE10 [hp_X]  in 29.6 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE10 [hp_X]  in 29.6 mL
    JUGLANS REGIA WHOLE (UNII: 87EJ76IO83) (JUGLANS REGIA WHOLE - UNII:87EJ76IO83) JUGLANS REGIA WHOLE10 [hp_X]  in 29.6 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 29.6 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 29.6 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 29.6 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED10 [hp_X]  in 29.6 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 29.6 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]  in 29.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-7225-11 in 1 CARTON
    129.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/04/2013
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-7225)