ERMIDRA- zinc gluconate shampoo 
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™ SHAMPOO

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:

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 - 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
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

Revised: 5/2022
Document Id: 2089b7a1-e7c4-46ae-b585-c5d58e0e452f
Set id: cfb86d0e-4d27-4426-8663-60f493fc2a1a
Version: 2
Effective Time: 20220526
 
Nextmune AB