Label: LEG AND BACK PAIN RELIEF- atropa belladonna,capsicum,citrullus colocynthis fruit pulp,magnesium phosphate, dibasic,toxicodendron radicans leaf,hypericum perforatum cream

  • NDC Code(s): 43689-0031-1, 43689-0031-2
  • Packager: The Magni Group Inc
  • 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 November 15, 2022

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  • ​Drug Facts

  • Active ingredients

    Banewort (Belladona) 3X HPUS

    Cayenne Pepper ( Capsicum annuum) 3X HPUS

    Colocynth ( Citrullus colocynthis) 3X HPUS

    Gnaphalium polycephalum 3X HPUS

    Magnesium Hydrogen Phosphate 3X HPUS

    Poison Ivy ( Rhus tox) 3X HPUS

    St. John's-Wort ( Hypericum perforatum) 3X HPUS

    The letters 'HPUS' indicate that the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States

    Purpose

    For aching back pain

    For pain while sitting

    For pain along back of thigh

    Pain reliever

    For leg and back pain

    For pain in the back of the legs

    For back pain

  • ​Use

    For the temporary relief of pain in the lowerback, buttocks, and legs.

  • ​Warnings

    ​For external use only.

    ​A​void contact with eyes.

    Stop use and ask a doctor if

    you experience worsening symptoms or if symptoms last longer than 7 days.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • ​Directions

    Generously apply and massage into skin from lower back to feet twice daily.

  • ​Other information

    • There is no scientific evidence that this product works.
    • The product’s claims are based on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
  • ​Inactive ingredients

    Aloe vera leaf juice, benzocaine, C13-14 isoparaffin, calendula flower extract, cayenne resin, cranesbill extract, dog rose flower extract, English lavender oil, European elder flower extract, fennel seed extract, folic acid, laurteth-7, magnesium ascorbyl phosphate, methylparaben, polyacrylamide, propylene glycol, propylparaben, retinyl palmitate, sage leaf extract, sage oil, tocopheryl acetate, bitter orange flower extract, water, yarrow extract

  • Package Labeling:

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  • INGREDIENTS AND APPEARANCE
    LEG AND BACK PAIN RELIEF 
    atropa belladonna,capsicum,citrullus colocynthis fruit pulp,magnesium phosphate, dibasic,toxicodendron radicans leaf,hypericum perforatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 113 g
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 113 g
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP3 [hp_X]  in 113 g
    MAGNESIUM PHOSPHATE, DIBASIC (UNII: A1Y870209Z) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC3 [hp_X]  in 113 g
    TOXICODENDRON RADICANS LEAF (UNII: CDH3461U7L) (TOXICODENDRON RADICANS LEAF - UNII:CDH3461U7L) TOXICODENDRON RADICANS LEAF3 [hp_X]  in 113 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOCAINE (UNII: U3RSY48JW5)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    FOLIC ACID (UNII: 935E97BOY8)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SAGE (UNII: 065C5D077J)  
    SAGE OIL (UNII: U27K0H1H2O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
    WATER (UNII: 059QF0KO0R)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43689-0031-1113 g in 1 JAR; Type 0: Not a Combination Product06/08/2017
    2NDC:43689-0031-21 in 1 BOX06/08/2017
    2113 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/08/2017
    Labeler - The Magni Group Inc (113501902)
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