Label: UNDA 1000- rubus fruticosus, spongia tosta, calendula officinalis, drosera 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 9, 2022

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  • ACTIVE INGREDIENT

    Active ingredients
    Calendula officinalis (Marigold) Flowering Tops 4X
    Drosera (Sundew) Whole Plant 4X
    Rubus fruticosus Leaf 4X
    Spongia tosta (Roasted sponge) 4X

  • PURPOSE

    Uses

    For the temporary relief of minor digestive upset and tiredness.

  • 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.

  • STOP USE

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), purified water

  • OTHER SAFETY INFORMATION

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

  • 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 minor digestive upset and tiredness.

    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.

  • PRINCIPAL DISPLAY PANEL

    62106-1173

    NDC 62106-1173-8

    UNDA
    numbered compounds
    UNDA 1000
    Homeopathic Preparation

    For the temporary relief of minor

    digestive upset and tiredness.
    Contains 31% Alcohol
    0.7 fl oz (20 ml)

  • INGREDIENTS AND APPEARANCE
    UNDA 1000 
    rubus fruticosus, spongia tosta, calendula officinalis, drosera liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1173
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9) (RUBUS FRUTICOSUS LEAF - UNII:YQ2S06L8S9) RUBUS FRUTICOSUS LEAF4 [hp_X]  in 20 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP4 [hp_X]  in 20 mL
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP4 [hp_X]  in 20 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED4 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1173-81 in 1 CARTON09/23/2015
    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 homeopathic09/23/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1173)
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