WARNINGS
Use the medicine according to the indicated methods of use. Prolonged use of topical products may lead to sensitization phenomena. In such cases, discontinue treatment and consult a veterinarian. Special precautions for use in animals: avoid using excess foam. Do not rinse. Do not dry with cloths or absorbent paper. Avoid contact with the eyes. Do not use simultaneously with other detergents. For external use only. Special precautions to be taken by the person administering the veterinary medicinal product to animals: individuals with known hypersensitivity to the active ingredients contained in this medicine should avoid contact with the veterinary medicinal product. During use, it is advisable to wear gloves. Avoid contact with the eyes. In case of contact, rinse the eyes with plenty of water. Do not ingest. In case of accidental ingestion, seek medical attention immediately showing the package leaflet or label. Chlorhexidine digluconate, Allantoin, and Bisabolol are contained in Deroxen Foam in modest quantities, making it very unlikely to administer excessive doses. The absorption of Chlorhexidine through the skin is negligible, therefore the administration of an excessive dose of Deroxen Foam has no consequences. Chlorhexidine, due to its low intestinal absorption, has low toxicity when taken orally: the LD50 orally is 1.8 g/Kg in mice. Regarding the tolerability of Chlorhexidine digluconate, extensive use in human and veterinary medicine has shown that only higher concentrations for topical use than 2% (equivalent to 11.2 mg/ml of Chlorhexidine base) may cause skin irritation, and that concentrations up to 0.2% (equivalent to 1.12 mg/ml of Chlorhexidine base) are tolerated even for ophthalmic treatments. Surfactants other than the one contained in Deroxen Foam may nullify the germicidal activity of Chlorhexidine; do not use simultaneously with other detergents or topical solutions containing borates, bicarbonates, carbonates, chlorides, citrates, nitrates, phosphates, sulfates.
PHARMACOTHERAPEUTIC CATEGORY
Antiseptics and disinfectants; chlorhexidine in combination.
STORAGE
Store at room temperature and protected from light. Shelf life of the veterinary medicinal product packaged for sale: 5 years.
CONTRAINDICATIONS/ADVERSE EFFECTS
Do not use in animals with known hypersensitivity to the active ingredients or to any of the excipients. See also paragraph 4.5. Do not use in nursing puppies.
NAME
DEROXEN FOAM SPRAY, 4 MG/ML CUTANEOUS FOAM FOR DOGS AND CATS
DIAGNOSIS AND PRESCRIPTION
Veterinary medicinal product without the obligation of veterinary medical prescription. Use is recommended after a veterinary consultation.
EXCIPIENTS
Cocamidopropyl betaine, isopropyl alcohol, purified water.
ADVERSE EFFECTS
In rare cases, animals may develop skin irritation after treatment.
PREGNANCY AND LACTATION
Chlorhexidine is not absorbed transcutaneously, and gastrointestinal absorption in case of ingestion is practically nil. The product can be used during pregnancy and lactation.
INDICATIONS
For the treatment of dermatological diseases in dogs and cats where a drastic reduction of pathogenic germs is needed topically and to simultaneously promote healing processes; in particular: infections caused by Malassezia; superficial pyodermas such as: intertrigo, impetigo, superficial folliculitis, pyotraumatic dermatitis; deep pyodermas such as: furunculosis, canine acne, pododermatitis; seborrhea associated with infections; dermatophytosis; and as a deodorant.
INTERACTIONS
Do not use simultaneously with other antiseptics. See paragraph 6.2.
DOSAGE
For external use only. Spray the foam and distribute it evenly over the entire body of the animal or only on the parts that need to be treated, ensuring penetration, in case the animal is not shaved, until contact with the skin. Depending on the length of the animal’s hair, administer: from 4 to 8 sprays/kg, corresponding to 11.5 mg and 23 mg of Chlorhexidine base per kg body weight, for the 200 ml package; from 2 to 4 sprays/kg corresponding to 12.5 mg and 25 mg of Chlorhexidine base per kg body weight, for the 350 ml package. At the end of treatment, the skin and hair should be uniformly damp. Gently comb the animal if necessary. Do not dry. Repeat initially every day or every other day, subsequently at longer intervals, at the discretion of the veterinarian, until remission.
ACTIVE INGREDIENTS
100 ml of solution contains: active ingredients: chlorhexidine digluconate (equivalent to g 0.4 of Chlorhexidine base) 0.71 g; allantoin 0.4 g; alpha-Bisabolol 1 g. Excipients: for the complete list of excipients see paragraph 6.1.
SAFETY IN TARGET SPECIES
Chlorhexidine digluconate, Allantoin, and Bisabolol are contained in Deroxen Foam in modest quantities, making it very unlikely to administer excessive doses. The absorption of Chlorhexidine through the skin is negligible, therefore the administration of an excessive dose of Deroxen Foam has no consequences. Chlorhexidine, due to its low intestinal absorption, has low toxicity when taken orally: the LD50 orally is 1.8 g/Kg in mice. Regarding the tolerability of Chlorhexidine digluconate, extensive use in human and veterinary medicine has shown that only higher concentrations for topical use than 2% (equivalent to 11.2 mg/ml of Chlorhexidine base) may cause skin irritation, and that concentrations up to 0.2% (equivalent to 1.12 mg/ml of Chlorhexidine base) are tolerated even for ophthalmic treatments.
TARGET SPECIES
Dogs and cats.
WITHDRAWAL TIME
Not applicable.
USE/ROUTE OF ADMINISTRATION
For external use only.