Label: ERMIDRA- zinc gluconate spray

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 26, 2022

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  • VETERINARY INDICATIONS

    Zinc gluconate rehydrating and soothing spray with propylene glycol for dogs and cats.

  • Composition:

    Active ingredient(s): zinc gluconate 1%.

    Inactive ingredient(s):

    cyclodextrins, D-panthenol, demineralized water, epilobium, fragrance, glycerin, isotridecanol ethoxylated, lecithin, preservatives (2-Bromo-2-nitropropane-1,3-diol, methylchloroisothiazolinone, methylisothiazolinone), propylene glycol.

  • Indications:

    Ermidra™ Zinc Gluconate Rehydrating and Smoothing Spray is indicated for the treatment of skin dehydration and irritation in dogs and cats caused by excessive external temperatures, where the normal physiological balance of the hydrolipidic film of the skin is altered. Use under the direction of a veterinarian as an adjuvant in the treatment of acute seborrheic states. For use in dogs and cats that require skin hydration. Use after shampooing. May also help rehydrate and soothe oily or dry, scaly skin.

  • Directions for use:

    Completely drench the entire haircoat until the skin becomes damp. Do not rinse. Spray against the direction the fur grows for animals with long or thick haircoats. Ermidra™ Zinc Gluconate Rehydrating and Smoothing Spray may be used several times per day.

    Image

    		Liposome
  • Properties:

    The key ingredients have the following properties:

    • Epilobium angustifolium extract is rich in astringent tannins which have soothing and emollient properties.
    • Zinc gluconate has anti-inflammatory and antioxidant properties. Helps normalize the skin and improve its physiologic condition.
    • D-panthenol is combined with beta-cyclodextrins to form a stable complex that provides hydration and elasticity to the epidermis, with a moisturizing effect.
    • Liposomes are moisturizing microcapsules with carrier function that allow the glycol to penetrate into the deeper layers of the skin, with an emollient action. Liposomes are intended to enhance penetration and provide progressive release of the moisturizing agent.
    • Propylene glycol has a moisturizing, humectant and keratolytic effect.
    • Glycerin has rehydrating and emollient action.
  • Precautionary statements:

    For external use on dogs and cats only. May cause eye irritation. Avoid contact with eyes. If in eyes: rinse cautiously with water for several minutes. Consult a veterinarian before using on pregnant, lactating or breeding animals; or animals with a pre-existing medical condition. Use with caution in older animals. If an animal has an adverse reaction to treatment, discontinue use and contact your veterinarian.

  • Warning:

    Keep out of reach of children.

  • Storage:

    Store at room temperature.

    Do not freeze.

  • SPL UNCLASSIFIED SECTION

    iCF™
    Evolution of
    Knowledge
    www.icfpet.com

    Distributor:

    Nextmune US, LLC
    2801 S. 35th St.,
    Phoenix, AZ 85034
    480-464-8971

    made
    in France

    Manufacturer:

    iCF™
    Evolution     of
    Knowledge

    a division of

    NEXTMUNE ITALY S.R.L.
    Via G.B. Benzoni, 50 26020
    PALAZZO PIGNANO (CR) Italy
    Tel. +39 0373 982024 +39 0373 938345
    e-mail: info@icfsrl.it - customercare@drnsrl.it

  • PRINCIPAL DISPLAY PANEL - 300 ml Bottle Carton

    Ermidrà™

    Spray

    Zinc gluconate rehydrating
    and soothing spray with
    propylene glycol

    for dogs and cats

    Developed in Italy

    iCF™
    Evolution of
    Knowledge

    10.5 fl. oz.(300 ml)

    PRINCIPAL DISPLAY PANEL - 300 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ERMIDRA 
    zinc gluconate spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86127-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    CYCLODEXTRINS (UNII: 7E6SK9QDT8)  
    ISOTRIDECYL ALCOHOL (UNII: VX3T72M5SG)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86127-007-051 in 1 CARTON
    1300 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/01/2022
    Labeler - Nextmune AB (352950223)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXTMUNE Italy SRL435856461MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Givaudan Lavirotte S.A.S282414770API MANUFACTURE
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