Label: UNDA 240- equisetum arvense, gentiana lutea, salvia officinalis, saxifraga granulata, spiraea ulmaria 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
    Each drop contains:
    Equisetum arvense (Common horsetail) Stem 6X
    Gentiana lutea (Yellow gentian) Underground Parts 6X
    Salvia officinalis (Garden sage) Leaf 6X
    Saxifraga granulata Aerial Parts 6X
    Spiraea ulmaria (Queen-of-themeadow) Underground Parts 6X

  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with growing pains.

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • OTHER SAFETY INFORMATION

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

  • 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 symptoms associated with growing pains.

    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

    62106-1161-8

    NDC 62106-1161-8

    UNDA

    numbered compounds

    UNDA 240

    Homeopathic Preparation

    For the temporary relief of symptoms associated with growing pains.

    Contains 31% Alcohol

    0.7 fl oz (20 ml)

  • INGREDIENTS AND APPEARANCE
    UNDA 240 
    equisetum arvense, gentiana lutea, salvia officinalis, saxifraga granulata, spiraea ulmaria liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) (FILIPENDULA ULMARIA ROOT - UNII:997724QNDS) FILIPENDULA ULMARIA ROOT6 [hp_X]  in 20 mL
    SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE6 [hp_X]  in 20 mL
    GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT6 [hp_X]  in 20 mL
    SAXIFRAGA GRANULATA FLOWERING TOP (UNII: G5005J3X2B) (SAXIFRAGA GRANULATA FLOWERING TOP - UNII:G5005J3X2B) SAXIFRAGA GRANULATA FLOWERING TOP6 [hp_X]  in 20 mL
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) (EQUISETUM ARVENSE BRANCH - UNII:1L0VKZ185E) EQUISETUM ARVENSE BRANCH6 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1161-81 in 1 CARTON12/14/2016
    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 homeopathic12/14/2016
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1161)
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