Label: UNDA 270- equisetum arvense, hypericum perforatum cream

  • 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 September 23, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients
    This preparation contains:
    Equisetum arvense (Common horsetail) Sterile Stem MT 0.1%
    Hypericum perforatum (St. John's wort) Whole Plant MT 0.1%

  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with

    dry skin

    itchy skin
    other minor skin irritations

  • WARNINGS

    Warnings
    For external use only.
    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. If swallowed, get medical help or contact a
    Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Cetostearyl alcohol, lanolin, lanolin alcohols, white petrolatum

  • OTHER SAFETY INFORMATION

    Other information
    Do not use if inner seal is missing or broken.

    Store in a cool, dry place

  • DOSAGE & ADMINISTRATION

    Directions
    Adults: Apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner.

    May cover affected area with sterile gauze after each application.

    Children: Use under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of symptoms associated with

    dry skin

    itchy skin
    other minor skin irritations

    Directions
    Adults: Apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner.

    May cover affected area with sterile gauze after each application.

    Children: Use under the direction of your healthcare practitioner.

  • PRINCIPAL DISPLAY PANEL

    62106-0097

    NDC 62106-0097-0

    UNDA topicals

    UNDA 270 OINTMENT

    Homeopathic Preparation

    For the temporary relief of symptoms
    associated with dry, itchy skin
    and other minor skin irritations.

    Net Weight 1.4 oz (40 g)

  • INGREDIENTS AND APPEARANCE
    UNDA 270 
    equisetum arvense, hypericum perforatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-0097
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM1 [hp_X]  in 40 g
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z) EQUISETUM ARVENSE TOP1 [hp_X]  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-0097-01 in 1 CARTON06/01/2015
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-0097)