CLX DERM OTO PIU: Product Information

CLX DERM OTO PIU- chlorhexidine gluconate solution
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.

oto piú Chlorhexidine digluconate ear cleanser for cats and dogs.

Properties: ClxDerm™ oto piú Chlorhexidine digluconate ear cleanser is an otic antiseptic solution designed for cleaning and moisturizing the ears of dogs and cats while providing a protective barrier against dirt and secretions that can attract bacteria. Contains moisturizers to help relieve itching. Chlorhexidine digluconate, the active ingredient in ClxDerm™ oto piú Chlorhexidine digluconate ear cleanser, has been proven effective against a broad-spectrum of micro-organisms sensitive to chlorhexidine. The use of ClxDerm™ oto piú will aid in the management of skin infections, supporting a healthy skin barrier.

Directions for use: Apply a few drops of the product into each ear canal and then gently message the base of the ear to spread the solution. Allow the solution to remain in the ear for several minutes before removing. Then, use a clean cotton ball to remove dirt or waxy build-up. No need to rinse ears. Allow the ear to dry after each treatment. May be applied 1-2 times per week or as directed by your veterinarian.

Composition:

ACTIVE INGREDIENT(S):

Chlorhexidine digluconate 0.15%.

INACTIVE INGREDIENT(S):

1,2-Hexanediol, Caprylyl glycol, Fragrance, Glycerophosphoinositol lysine salt, Lactobionic acid, Propylene glycol, Purified water.

Precautionary statements:

For external use in the ear canals of dogs and cats only. May cause skin or eye irritation. Avoid getting solution in your pet’s eyes. In case of contact with eyes, rinse thoroughly with water and consult a veterinarian. If skin irritation occurs and persists, discontinue use and contact your veterinarian. Consult a veterinarian before using on pregnant, lactating or breeding animals; puppies; kittens; or animals with a pre-existing medical condition. Use with caution in older animals. Do not use in animals with damaged eardrums. 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.

www.icfpet.com

Distributor:
Nextmune US, LLC
2801 S. 35th St.,
Phoenix, AZ 85034
480-464-8971

made
in Spain

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

To KNOW MORE
ABOUT piú

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PRINCIPAL DISPLAY PANEL — 150 ml Bottle Carton

CLXDerm™

oto piú

Chlorhexidine digluconate
ear cleanser
for cats and dogs

Developed in Italy

iCF™

Evolution ofKnowledge

5.07 fl. oz.(150 ml)

PRINCIPAL DISPLAY PANEL -- 150 ml Bottle Carton
(click image for full-size original)
CLX DERM OTO PIU chlorhexidine gluconate solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86127-002
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 1.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
GLYCEROPHOSPHOINOSITOL LYSINE
PROPYLENE GLYCOL
LACTOBIONIC ACID
CAPRYLYL GLYCOL
1,2-HEXANEDIOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86127-002-02 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 150 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (86127-002-02)
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
Medichem SA 464043381 API MANUFACTURE

Revised: 01/2022 Nextmune AB

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