Label: UNDA 270- calendula officinalis, dulcamara, equisetum arvense, hypericum perforatum 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 July 15, 2021

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  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:
    Calendula officinalis (Marigold) Aerial Parts 4X
    Dulcamara (Bittersweet) Shoots 4X
    Equisetum arvense (Common Horsetail) Stem 4X
    Hypericum perforatum (St. John’s Wort) Whole Plant 4X

  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with
    minor skin irritation
    occasional headache

  • 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.

  • 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.

    Contents may not fill package in order
    to accommodate required labeling.
    Please rely on stated quantity.

  • 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
    minor skin irritation
    occasional headache

    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

    62106-1166-8

    NDC 62106-1166-8

    UNDA

    numbered compounds

    UNDA 270

    Homeopathic Preparation

    For the temporary relief of symptoms associated

    with minor skin irritation and occasional headache.

    Contains 31% Alcohol

    0.7 fl oz (20 ml)

  • INGREDIENTS AND APPEARANCE
    UNDA 270 
    calendula officinalis, dulcamara, equisetum arvense, hypericum perforatum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1166
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SOLANUM DULCAMARA STEM (UNII: IR986LE7DF) (SOLANUM DULCAMARA STEM - UNII:IR986LE7DF) SOLANUM DULCAMARA STEM4 [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
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) (EQUISETUM ARVENSE BRANCH - UNII:1L0VKZ185E) EQUISETUM ARVENSE BRANCH4 [hp_X]  in 20 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM4 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1166-81 in 1 CARTON10/17/2017
    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 homeopathic10/17/2017
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1166)
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