Label: ADVANCED ARNICA PLUS- arnica montana, arnica montana, radix, bellis perennis, bryonia, hypericum perforatum, lithium carbonicum, magnesia phasphorica, phytolacca decandra, rhus toxicdendron, ruta gravedens 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 August 26, 2022

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • Direction

    Initially, depress pump until primed.

    Spray one dose directly into mouth.

    Adults: 3 sprays 3 times per day.

    Children ages 6-12: 2 sprays 3 times per day.

    Consult a physician for use in children under 6 years of age.

    Use additionally as needed, up to 6 times per day.

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  • OTHER SAFETY INFORMATION

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

    This product has not been clinically tested.

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  • Active ingredients

    Arnica montana, Arnica montana, radix, Bellis, Bryonia, Hypericum, Lithium carb, Mag phos, Phytolacca, Rhus tox, Ruta. 

    Equal volumes of each HPUS ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

    Reference image: AdvancedArnicaPlus1jpeg.jpg

  • Uses

    Temporarily relieves symptoms due to injury or overexertion: bruises, muscle pain,

    inflammation, body aches, soreness after exercise.

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  • Inactive Ingredients

    Citrus Entract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extract, 

    demimeralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified water, Shagbark Hickory (Carya ovata) Bark

    Extract, Steviol (Steviol glycosides).

    Reference image: AdvancedArnicaPlus1jpeg.jpg

  • PURPOSE

    For temporary relief of:

    Aches and Pains

    Exercise soreness

    Temporarily relieves symptoms due to injury or overexertion: bruises, muscle pain,

    inflammation, body aches, soreness after exercise.

    Reference image: AdvancedArnicaPlus1jpeg.jpg

  • PRINCIPAL DISPLAY PANEL

    image description AdvancedArnicaPlus1jpeg.jpg

  • INGREDIENTS AND APPEARANCE
    ADVANCED ARNICA PLUS 
    arnica montana, arnica montana, radix, bellis perennis, bryonia, hypericum perforatum, lithium carbonicum, magnesia phasphorica, phytolacca decandra, rhus toxicdendron, ruta gravedens liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-3004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE10 [hp_X]  in 59 mL
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT10 [hp_X]  in 59 mL
    BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS WHOLE10 [hp_X]  in 59 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 59 mL
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE10 [hp_X]  in 59 mL
    LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE10 [hp_X]  in 59 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 59 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT10 [hp_X]  in 59 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 59 mL
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    STEVIOL (UNII: 4741LYX6RT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-3004-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/27/2022
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-3004) , api manufacture(57955-3004)
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