ERMIDRA- zinc gluconate spray 
Nextmune AB

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ERMIDRÀ™ SPRAY

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:

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.

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
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

Revised: 5/2022
Document Id: e22f921c-5b31-4002-b018-497f0fdc1e9a
Set id: fd8a0391-9896-4c6b-bbe3-42c6bfc66f4f
Version: 2
Effective Time: 20220526
 
Nextmune AB