TOPIZOLE MEDICATED SHAMPOO

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CHLORHEXIDINE GLUCONATE; MICONAZOLE NITRATE

Available from:

MAVLAB PTY. LTD.

INN (International Name):

chlorhexidine gluconate(20g/L)+miconazole nitrate(20g/L)

Pharmaceutical form:

TOPICAL SOLUTION/SUSPENSION

Composition:

CHLORHEXIDINE GLUCONATE GUANIDINE Active 20.0 g/L; MICONAZOLE NITRATE TRIAZOLE Active 20.0 g/L

Units in package:

1L; 250mL; 500mL; 5L

Class:

VM - Veterinary Medicine

Therapeutic area:

DERMATOLOGICAL PREPS.

Product summary:

Poison schedule: 6; Withholding period: WHP: N/A; Host/pest details: CAT: [BACTERIA, DERMATOLOGICAL CONDITION, FUNGAL DISEASES, YEAST]; DOG: [BACTERIA, DERMATOLOGICAL CONDITION, FUNGAL DISEASES, YEAST]; Poison schedule: 6; Withholding period: ; Host/pest details: CAT: [BACTERIA, DERMATOLOGICAL CONDITION, FUNGAL DISEASES, YEAST]; DOG: [BACTERIA, DERMATOLOGICAL CONDITION, FUNGAL DISEASES, YEAST]; Topical medicated germicidal shampoo for dogs and cats. A dermatological shampoo effective on dogs and cats against chlorhexidine-sensitive and miconazole-sensitive bacteria, fungi and yeast.See PRECAUTIONS etc. on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

-------------------------------------------------
APPENDIX2
TEMPLATE
PRODUCTS)
FOR
RELEVANT
LABEL
PARTICULARS
(RLPS)
(VETERINARY
Select appropriate:
DX
New Product (include all applicable RLPs) OR
D
Variation (highlight instructions that are being varied). Approval no.
of
label being
varied:
Signal
heading:
POISON
KEEP OUT
OF
REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
Product
name:
TOPIZOLE MEDICATED SHAMPOO
Active
Chlorhexidine gluconate
20
g/L
CONSTITUENVS:
Miconazole nitrate
20
g/L
Statement
of
Topical medicated germicidal shampoo for dogs and cats.
CLAIMS:
A dermatological shampoo effective on dogs and cats against
chlorhexidine-
sensitive and miconazole-sensitive bacteria, fungi and yeast.
Net
contents:
250
mL
[500
ml/
1
L/5
L]
Directions for
Use
•
For use as an aid
in
the treatment
of
non-specific dermatological
Heading:
conditions
in
dogs and cats.
•
For use associated with skin conditions that may benefit from the
elimination or reduction
of
bacteria, fungi and yeasts that are
responsive to chlorhexidine gluconate and miconazole nitrate.
•
For use as a general
an!"1-bacterial,
anti-fungal topical shampoo
treatment.
0
For use to clean and condition coats.
Restraints:
Contraindications:
PRECAUTIONS:
1"
Use with caution around eyes. If shampoo enters animal's eyes, flush
thoroughly with clean water. Seek veterinary advice if eye changes are
observed.
2.
Animals should not
be
left unattended during the recommended
10
minute shampoo contact time,
as
licking or inhaling shampoo foam
may result
in
irritation
of
the gastrointestinal or respiratory
tracts_
3.
This product
is
not recommended for use in rabbits or species other
than dogs and cats.
Side
effects:
Dosage&.
Wet the animal thoroughly with clean water. Apply Topizole Medicated
ADMINISTRATION:
Shampoo to the animal at several points and massage into the coat. A
sponge
assists lathering and penetration of shampoo into the coat. Ensure
that
Topizole Medicated Shampoo
is
applied around the lips, under the