ERMIDRA- zinc gluconate spray

ERMIDRA by

Drug Labeling and Warnings

ERMIDRA by is a Animal medication manufactured, distributed, or labeled by Nextmune AB, NEXTMUNE Italy SRL, Givaudan Lavirotte S.A.S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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)

INGREDIENTS AND APPEARANCE

ERMIDRA 
zinc gluconate spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86127-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86127-007-05	1 in 1 CARTON
1		300 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/01/2022

Labeler - Nextmune AB (352950223)

Establishment
Name	Address	ID/FEI	Business Operations
NEXTMUNE Italy SRL		435856461	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Givaudan Lavirotte S.A.S		282414770	API MANUFACTURE