KORIUM WOUND CARE (CALENDULA OFFICINALIS 1X HPUS) SPRAY [GR8BIO LLC]

KORIUM WOUND CARE (CALENDULA OFFICINALIS 1X HPUS) SPRAY [GR8BIO LLC]
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NDC 70811-001-00
Set ID 441eb19f-4280-01b7-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager GR8BIO LLC
Generic Name
Product Class
Product Number
Application Number
  • 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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