Label: PAIN AND ITCH RELIEF- daphne mezereum bark, gelsemium sempervirens root gel

  • NDC Code(s): 43689-0029-1, 43689-0029-2
  • Packager: Magni Group
  • 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

    Mezereum (Daphne mezereum) 6X HPUS 

    Yellow Jessamine ( Gelsemium Sempervirens) 6X HPUS. 

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

    Purpose

    Anti-itch External analgesic

  • Use

    For temporary relief of pain, itch, and minor skin irritation.

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Stop use 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

    • Apply generously to affected areas up to 4 times a day
  • 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

    Alcohol, aloe vera leaf juice, ascorbic acid, bitter orange flower extract, C13-14 isoparaffin, calendula flower extract, caramel color, carbomer 940, chamomile flower extract, cranesbill extract, dog rose flower extract , echinacea angustifolia extract, english lavendar oil, european elder flower extract, fennel extract, glycerin, laureth-7, lysine, phenylpropanol, piperonal, polyacrylamide, potassium sorbate, PPG-2 methyl ether, propylene glycol, sage leaf extract, sodium benzoate, tea tree leaf oil, tocopheryl acetate, triethanolamine, water, wintergreen oil, witch hazel, yarrow extract

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    PAIN AND ITCH RELIEF 
    daphne mezereum bark, gelsemium sempervirens root gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK6 [hp_X]  in 51 g
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 51 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CARAMEL (UNII: T9D99G2B1R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LYSINE (UNII: K3Z4F929H6)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    PIPERONAL (UNII: KE109YAK00)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SAGE (UNII: 065C5D077J)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43689-0029-11 in 1 BOX07/06/2017
    151 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:43689-0029-251 g in 1 JAR; Type 0: Not a Combination Product07/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/06/2017
    Labeler - Magni Group (113501902)
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