Label: BACK, MUSCLE AND JOINT RELIEF- aesculus hipp, arnica, bellis, bryonia, calc carb, calc fluor, cimicifuga, cobaltum met, gnaphalium poly, hypericum, kali carb, kali phos, mag phos, oxalicum ac, phos, rhus tox, ruta, zinc met 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 September 28, 2022

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

  • 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.

    Reference image: Back.jpg

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Reference image: Back.jpg

  • Directions

    Initially, depress pump until
    primed. Spray one dose directly into mouth.

    Adults: 3 sprays 3 times per day.

    Children (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.

    Reference image: Back.jpg

  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use
    only if seal is intact. This product has not been
    clinically tested.

    King Bio, Inc. FDA Reg. #1053442
    3 Westside Dr. Asheville, NC 28806 USA
    Questions? Call 866.298.2740

    Reference image: Back.jpg 

  • Active ingredients

    Aesculus hipp, Arnica, Bellis, Bryonia, Calc carb, Calc fluor, Cimicifuga, Cobaltum met, Gnaphalium poly, Hypericum, Kali carb, Kali phos, Mag phos, Oxalicum ac, Phos, Rhus tox, Ruta, Zinc met.

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

    Reference image: Back.jpg

  • Uses

    For temporary relief of symptoms: back
    pain, sprains and strains, acute pain and injury,
    muscle cramps, tension and stiffness.

    Reference image: Back.jpg

  • Inactive ingredients

    Citrus Extract (ascorbic
    acid, citric acid, citrus aurantium amara fruit
    extract, citrus aurantium sinensis peel extract,
    citrus reticulata fruit extract, demineralized water,
    glycerin, lactic acid), Honeysuckle (Lonicera
    japonica), Polylysine, Purified Water, Shagbark
    Hickory (Carya ovata) Bark Extract, Steviol
    (Steviol glycosides).

    Reference image: Back.jpg

  • PURPOSE

    For temporary relief of symptoms:

    back pain

    sprains and strains

    acute pain and injury

    muscle cramps

    tension and stiffness

    Reference image: Back.jpg

  • PRINCIPAL DISPLAY PANEL

    image description Back.jpg

  • INGREDIENTS AND APPEARANCE
    BACK, MUSCLE AND JOINT RELIEF 
    aesculus hipp, arnica, bellis, bryonia, calc carb, calc fluor, cimicifuga, cobaltum met, gnaphalium poly, hypericum, kali carb, kali phos, mag phos, oxalicum ac, phos, rhus tox, ruta, zinc met liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0261
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT10 [hp_X]  in 59 mL
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE10 [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
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 59 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE10 [hp_X]  in 59 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 59 mL
    COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362) COBALT10 [hp_X]  in 59 mL
    PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE10 [hp_X]  in 59 mL
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE10 [hp_X]  in 59 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE10 [hp_X]  in 59 mL
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE10 [hp_X]  in 59 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 59 mL
    OXALIC ACID DIHYDRATE (UNII: 0K2L2IJ59O) (OXALIC ACID - UNII:9E7R5L6H31) OXALIC ACID DIHYDRATE10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [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
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC10 [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, UNSPECIFIED FORM (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:57955-0261-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/23/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/23/2022
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture(57955-0261) , api manufacture(57955-0261)