UNDA 270 (CALENDULA OFFICINALIS, DULCAMARA, EQUISETUM ARVENSE, HYPERICUM PERFORATUM) LIQUID [SEROYAL USA]

UNDA 270 (CALENDULA OFFICINALIS, DULCAMARA, EQUISETUM ARVENSE, HYPERICUM PERFORATUM) LIQUID [SEROYAL USA]
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NDC 62106-1166-8
Set ID 5bb0acb9-be37-7096-e053-2a91aa0adf1c
Category HUMAN OTC DRUG LABEL
Packager Seroyal USA
Generic Name
Product Class
Product Number
Application Number
  • 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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