FILTA-BAC SUNFILTER AND ANTI-BACTERIAL CREAM

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

13-09-2017

Summary of Product characteristics (SPC)

13-09-2017

Active ingredient:

TITANIUM DIOXIDE; ZINC OXIDE; BENZALKONIUM CHLORIDE; CETRIMIDE

Available from:

ROBIN PHARMACEUTICALS LIMITED

INN (International Name):

titanium dioxide(140g/kg)+zinc oxide(80g/kg)+cetrimide(3g/kg) + others

Pharmaceutical form:

TOPICAL CREAM, OINTMENT, PASTE, GEL, LOTION

Composition:

TITANIUM DIOXIDE MINERAL-TITANIUM Active 140.0 mg/g; ZINC OXIDE MINERAL-ZINC Active 80.0 mg/g; BENZALKONIUM CHLORIDE AMMONIUM-QUATERNARY Active 0.8 mg/g; CETRIMIDE AMMONIUM-QUATERNARY Active 3.0 mg/g

Units in package:

120g; 220g; 2kg; 500g; 50g

Class:

VM - Veterinary Medicine

Manufactured by:

DIMEL

Therapeutic group:

Therapeutic area:

DERMATOLOGICAL PREPS.

Therapeutic indications:

Product summary:

Poison schedule: 0; Withholding period: WITHHOLDING PERIODS: Zero (0) days EXPO RT SLAUGHTER INTERVAL (ESI): Zero (0) da ys. Before using this product, confirm the current ESI from CEVA ANIMAL HEALTH Pty Ltd on (02) 96527000 or the APVMA w ebsite (www.apvma.gov.au/residues).; Host/pest details: CATTLE: [ANTIBIOTIC - ANTI-INFECTIVE, CRACKING & CHAPPING OF TEAT, PROTECTION AGAINST SUNBURN, WOUND DRESSING]; DOG: [ANTIBIOTIC - ANTI-INFECTIVE, PROTECTION AGAINST SUNBURN, WOUND DRESSING]; GOAT: [ANTIBIOTIC - ANTI-INFECTIVE, PROTECTION AGAINST SUNBURN, WOUND DRESSING]; HORSE: [ANTIBIOTIC - ANTI-INFECTIVE, PROTECTION AGAINST SUNBURN, WOUND DRESSING]; SHEEP: [ANTIBIOTIC - ANTI-INFECTIVE, PROTECTION AGAINST SUNBURN, WOUND DRESSING]; Antibacterial, antiseptic and wound protectant cream with sun filter for use on dogs, horses, cattle, sheep and goats.See Precautions on label (allergic skin reactions & renal failure)

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

FILTA-BAC SUNFILTER AND ANTI-BACTERIAL CREAM
36716/111674
Product Name:
APVMA Approval No:
Label Name:
FILTA-BAC SUNFILTER AND ANTI-BACTERIAL CREAM
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
ACTIVE CONSTITUENTS [per g]: 140 mg Titanium Dioxide, 80 mg Zinc
Oxide, 3 mg
Cetrimide, 0.8 mg Benzalkonium chloride
Claims:
Antibacterial, antiseptic, and wound protectant cream with sunfilter.
For use on horses, dogs, cattle, sheep and goats.
Net Contents:
50 g [120 g, 220 g, 500 g, 2 kg]
Directions for Use:
Restraints:
Contraindications:
Precautions:
In the case of allergic skin reaction cease application and wash area
with warm water and
mild soap.
For animals with renal failure, avoid frequent daily applications of
FILTA-BAC over large
areas of the body.
Apply to dairy animals after milking.
Side Effects:
Dosage and
Administration:
Use FILTA-BAC to treat the following conditions:
Sunfilter: When required, apply a thin layer of FILTA-BAC to exposed
skin up to 3 times
daily. Every 3rd day clean completely before reapplication. RLP APPROVED
Antibacterial & Antiseptic: Apply a covering layer of FILTA-BAC to
damaged skin areas
at least daily until healed. For dairy animals with teat and udder
sores, apply FILTA-BAC
immediately after milking and remove any remaining FILTA-BAC before
next milking by
bathing area with warm water and mild soap. Rinse well.
Wound protection: First clean the affected areas by removing any
excess dirt with mild
soap and warm water. Then apply FILTA-BAC daily & every 3rd day clean
completely
before reapplication.
If the condition fails to respond to treatment, seek veterinary
advice.
General Directions:
Withholding Periods:
WITHHOLDING PERIODS: Zero (0) days
Trade Advice:
EXPORT SLAUGHTER INTERVAL (ESI): Zero (0) days. Before using this
product, confirm
the current ESI from CEVA ANIMAL HEALTH Pty Ltd on (02) 96527000 or
the APVMA
website (www.apvma.gov.au/residues).
Safety Directions:
First Aid Instructions:
If poisoning occurs, contact a doctor or Poisons Information Centre.

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Summary of Product characteristics

1.
IDENTIFICATION OF THE
SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Robin Pharmaceuticals Ltd
12 Ngareta Road
Mourea
ROTORUA
NEW ZEALAND
EMERGENCY TELEPHONE
Mobile +64 27 2954750
PH: +64 7 362 4643
SAFETY DATA SHEET
PRODUCT NAME:
FILTA-BAC CREAM
PRODUCT CODE:
ACVM A002039 (NZ)
NRA 367/1297 (AUS)
2.
HAZARD IDENTIFICATION:
Nil
3.
COMPOSITION/INFORMATION ON INGREDIENTS:
Oil in water cream with:
140mg Titanium Dioxide:
80mg Zinc Oxide:
3mg Cetrimide: 0.8mg Benzalkonium Chloride.
4.
FIRST AID MEASURES
CONTACT WITH SKIN:
Safe
CONTACT WITH EYES:
Not hazardous: Bathe with normal saline or water
INGESTION:
Not hazardous: Give milk or water.
Do not induce vomiting.
INHALATION:
N/A
OTHER INFORMATION:
N/A
5.
FIRE FIGHTING MEASURES:
N/A
6.
ACCIDENTAL RELEASE MEASURES:
Shovel up spillages. Wash away with water.
Dispose in refuse.
7.1
HANDLING:
Avoid impact likely to break container.
7.2
STORAGE:
Below 30ºC: Do not freeze.
8.1
EXPOSURE CONTROLS/PERSONAL PROTECTION:
Normal Protective Clothing.
8.2
EXPOSURE LIMITS:
N/A
9.
PHYSICAL AND CHEMICAL PROPERTIES:
White Medium spreadable cream
Medium Viscosity
Melting point:
45ºC - 48ºC
pH:
7.0 - 7.5
10.
STABILITY AND REACTIVITY:
Stable: Life to expiry 36 months.
11.
TOXICOLOGICAL INFORMATION:
Non toxic
12.
ECOLOGICAL INFORMATION:
EPA/HSNO 9.1A: Aquatic ecotoxicant
13.
DISPOSAL CONSIDERATIONS:
Disposal should be in accordance with local, state or
national legislation.
14.1
TRANSPORT REGULATIONS:
Proper name ID.
NOT APPLICABLE
14.2
TRANSPORT INFORMATION:
Not classified as hazardous for transport.
15.
REGULATORY INFORMATION:
Veterinary Medicine (Non-dispersive open system)
HSR100759
15.1
RISK PHASES:
None assigned
15.2
SAFETY PHRASES:
None assigned
16.
OTHER INFORMATION:
N/A

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