ERMIDRA- zinc gluconate shampoo

ERMIDRA by

Drug Labeling and Warnings

ERMIDRA by is a Animal medication manufactured, distributed, or labeled by Nextmune AB, NEXTMUNE Italy SRL, Medichem SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ERMIDRA 
zinc gluconate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86127-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86127-006-01	1 in 1 CARTON
1		250 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