Label: KORIUM WOUND CARE- calendula officinalis 1x hpus spray

  • 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 January 24, 2020

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  • ACTIVE INGREDIENT

    Calendula Officinalis 1X HPUS -2%

  • PURPOSE

    Healing Agent

  • INDICATIONS & USAGE

    May help promote healing of minor cuts, scratches and chafing.

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE if you are allergic to Calendula officinalis or to any of this product's inactive ingredients.

  • WHEN USING

    WHEN USING THIS PRODUCT:

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    You may experience some transient mild pain on the wound area.

  • STOP USE

    STOP USE AND ASK DOCTOR IF YOU:

    Have any allergic reaction to this product.

    Experience a deep or puncture wound, animal bite, or serious burn.

  • KEEP OUT OF REACH OF CHILDREN

    KWEEP OUT OF REACH OF CHILDREN. If swallowed get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • clean affected area thoroughly before applying
    • apply spray twice a day (every 12 hours) on affected area until entirely covered.
    • let dry and cover with a sterile bandage to promote healing.
    • continue use as needed
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    Store at room temperature 68-77°F (20-25°C).

    Do not use if tamper evident seal is broken.

  • INACTIVE INGREDIENT

    Butylated Hydroxytoluene

    Ethanol

    Polyethylene Glycol

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    KORIUM  WOUND CARE
    calendula officinalis 1x hpus spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70811-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE1 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70811-001-0020 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/20/2016
    Labeler - GR8BIO LLC (080291999)
    Registrant - Homeocare Laboratories Inc. (088248828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Homeocare Laboratories Inc.088248828manufacture(70811-001)
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