Label: UNDA 17- jateorhiza palmata, boldo leaf, rhamnus frangula, scabiosa succisa underground parts, valeriana officinalis, dulcamara, rumex crispus, argentum metallicum 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 November 8, 2022

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  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:
    Argentum metallicum (Silver) 12X
    Boldo Leaf 4X
    Dulcamara (Bittersweet) Shoots 4X
    Jateorhiza palmata (Columbo) Root 4X
    Rhamnus frangula (Buckthorn) Bark 4X
    Rumex crispus (Curly dock) Underground Parts 4X
    Scabiosa succisa (Devil's Bit) Underground Parts 4X
    Valeriana officinalis (Valerian) Root 4X

  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with
    mild skin irritation

    poor digestion

  • WARNINGS

    Warnings

    Stop use and ask a doctor if symptoms persist or worsen.

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a
    Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a

    Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Ethanol (beet),
    purified water

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and adolescents (12 years and older)

    Take 5 drops three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of symptom sassociated with
    mild skin irritation

    poor digestion

    Directions
    Adults and adolescents (12 years and older)

    Take 5 drops three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • OTHER SAFETY INFORMATION

    Other information
    Do not use if seal is missing or broken.
    Store in a cool, dry place.

  • PRINCIPAL DISPLAY PANEL

    62106-1116-8

    NDC 62106-1116-8

    UNDA

    numbered compounds

    UNDA 17

    Homeopathic Preparation

    For the temporary relief of symptoms

    associated with mild skin irritation

    and poor digestion.

    Contains 31% Alcohol
    0.7 fl oz (20 ml)

  • INGREDIENTS AND APPEARANCE
    UNDA 17 
    jateorhiza palmata, boldo leaf, rhamnus frangula, scabiosa succisa underground parts, valeriana officinalis, dulcamara, rumex crispus, argentum metallicum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    JATEORHIZA CALUMBA ROOT (UNII: V36I2B8LD5) (JATEORHIZA CALUMBA ROOT - UNII:V36I2B8LD5) JATEORHIZA CALUMBA ROOT4 [hp_X]  in 20 mL
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF4 [hp_X]  in 20 mL
    FRANGULA ALNUS BARK (UNII: S2D77IH61R) (FRANGULA ALNUS BARK - UNII:S2D77IH61R) FRANGULA ALNUS BARK4 [hp_X]  in 20 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN4 [hp_X]  in 20 mL
    CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT4 [hp_X]  in 20 mL
    SOLANUM DULCAMARA STEM (UNII: IR986LE7DF) (SOLANUM DULCAMARA STEM - UNII:IR986LE7DF) SOLANUM DULCAMARA STEM4 [hp_X]  in 20 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT4 [hp_X]  in 20 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER12 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1116-81 in 1 CARTON02/06/2015
    120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/06/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1116)
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