ERMIDRA: Product Information

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.

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.

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
(click image for full-size original)
ERMIDRA zinc gluconate shampoo
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86127-006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC GLUCONATE (ZINC CATION) ZINC GLUCONATE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
WHEY
SODIUM C12-14 PARETH-3 SULFATE
COCAMIDOPROPYL BETAINE
PEG-2 STEARATE
SAGE
METHYLPARABEN
BRONOPOL
METHYLISOTHIAZOLINONE
METHYLCHLOROISOTHIAZOLINONE
EPILOBIUM ANGUSTIFOLIUM LEAF
SODIUM HYDROXIDE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86127-006-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 250 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (86127-006-01)
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 Operations
NEXTMUNE Italy SRL 435856461 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Givaudan Lavirotte S.A.S 282414770 API MANUFACTURE

Revised: 05/2022 Nextmune AB

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