Label: ERMIDRA- zinc gluconate shampoo

  • 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

    Ermidrà™ Zinc gluconate shampoo for dogs and cats

  • Composition:

    Active ingredient(s):

    zinc gluconate 2%.

    Inactive ingredient(s):

    cocamidopropyl betaine, deionized water, epilobium, glycolic extract of sage, perfumed essences, PEG-2 stearate, preservatives (2-Bromo-2-nitropropane -1,3-diol Methylisothiazolinone Methylchloroisothiazolinone, Methylparaben), silicone emulsions, sodium chloride, sodium hydroxide, sodium laureth sulfate, whey.

  • Directions for use:

    Completely wet the haircoat of the animal with lukewarm water. Apply the product and gently message into the fur for at least 5 minutes. Rinse and dry the animal. Repeat 2-3 times a week initially until irritation resolves.

  • Precautionary statements:

    For external use on dogs, puppies 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.

  • Properties:

    Ermidrà™ Zinc gluconate shampoo for dogs and cats gently and deeply cleanses the skin and hair, rebalancing the physiological cellular state. Zinc gluconate has a soothing (anti-inflammatory) action by reducing the activation of keratinocytes and decreasing the production of TNF; it is also a strong antioxidant. The whey is able to soothe, refresh and rehydrate the skin to help maintain its physiological integrity.

  • Indications:

    Ermidrà™ zinc gluconate shampoo for dogs and cats is indicated:

    • for red and inflamed skin (rubbing, hyperreactivity);
    • sensitive skin.
  • SAFE HANDLING WARNING

    Warning: Keep out of reach of children.

  • STORAGE AND HANDLING

    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 - 250 ml Bottle Carton

    Ermidrà™

    Zinc gluconate
    shampoo
    for dogs and cats

    Developed in Italy

    iCF™
    Evolution of
    Knowledge

    8.45 fl. oz.(250 ml)

    Principal Display Panel - 250 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ERMIDRA 
    zinc gluconate shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86127-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    WHEY (UNII: 8617Z5FMF6)  
    SODIUM C12-14 PARETH-3 SULFATE (UNII: 5G80BO01PI)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-2 STEARATE (UNII: 94YQ11Y95F)  
    SAGE (UNII: 065C5D077J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86127-006-011 in 1 CARTON
    1250 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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