Label: RELAXING LEG CREAM HOMEOPATHIC PM- causticum, pseudognaphalium obtusifolium cream

  • NDC Code(s): 43689-0027-1, 43689-0027-2
  • 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 December 11, 2024

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  • ​Drug Facts

  • ​Active ingredients

    Causticum 8X HPUS

    Gnaphalium polycephalum 6X HPUS

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

    ​Purpose

    Nighttime Sleep Aid

    Pain Reliever

  • ​Use

    For temporary relief of leg discomfort with accompanying sleeplessness.

  • ​Warnings

    ​For external use only.​

    Avoid contact with eyes.

    ​Stop and ask a doctor

    if symptoms persist for more than 7 days or worsen.

    ​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 legs before bedtime.  Reapply if necessary.
  • ​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 Hydrochloride, C13-14 Isoparaffin, Diazolidinylurea, English Lavender Oil, Folic Acid, Laureth-7, Magnesium Ascorbyl Phosphate, Methylparaben, Polyacrylamide, Propylene Glycol, Propylparaben, Retinyl Palmitate, Roman Chamomile Flower Extract, Sage Leaf Extract, Soybean Oil, Tocopheryl Acetate, Water, Ylang Ylang Flower Extract

  • ​Package Labeling:

    JarBox

  • INGREDIENTS AND APPEARANCE
    RELAXING LEG CREAM HOMEOPATHIC PM 
    causticum, pseudognaphalium obtusifolium cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM8 [hp_X]  in 113 g
    PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM6 [hp_X]  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOCAINE HYDROCHLORIDE (UNII: OG625Z9LEO)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    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)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43689-0027-1113 g in 1 JAR; Type 0: Not a Combination Product05/24/2017
    2NDC:43689-0027-21 in 1 JAR05/24/2017
    2113 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/24/2017
    Labeler - The Magni Group Inc (113501902)
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