PROPRIETARY NAME AND DOSAGE FORM
AUTHORISATION
F10 GERMICIDAL BARRIER OINTMENT (Semi-solid ointment)
Registration No.: Act 36/1947 G3108, VMD Schedule 6 SAES:GMP M7586 WDA
32613APVMA 58544, SAES and FDA MUMS Index, MIF 900-009.
F10 GERMICIDAL BARRIER OINTMENT WITH INSECTICIDE (Semisolid ointment)
Registration No.: Act 36/1947 G4048, SAES EU Directive 2001/82/EC (art 4.2) and FDA MUMS Index, MIF 900-011.
COMPOSITION
Benzalkonium chloride …………………………………………………. 0.40g/100g
Polyhexanide ………………………………………………………………. 0.03g/100g
Glycol ………………………………………………………………………. 83.50g/100g
Lanolin ………………………………………………………………………..4.00g/100g
Non toxic excipients ……………………………………………………… to balance
Insecticide Additions
Cypermethrin ……………………………………………………………….0.25g/100g
Piperonyl Butoxide ………………………………………………………..1.25g/100g
INDICATIONS
An antiseptic preparation effective against bacteria, fungi and viruses to treat open and contaminated wounds and to prevent re-infestation. Also available with long lasting insecticide to repel insects and eliminate fly strike infestations.
ANTIMICROBIAL ACTION
The antimicrobial action of the preparation is based upon the proprietary branded F10 compound. The mechanism of action of F10 is derived from those of each component taken separately, in addition to those due to the additive synergistic action of all components combined. At the concentrations in the product F10 has been assessed as giving a >log4 reduction in microbial counts against gram positive and gram negative bacteria; fungi, yeasts and moulds; enveloped and non-enveloped viruses; bacterial and fungal spores.
INSECTICIDAL ACTION
The insecticidal action is based upon cypermethrin (a pyrethroid) and aided by piperonyl butoxide. In the testing phases the indicator species used was Lucilia cuprina, a commonly occurring blow fly species. As soon as the larvae were sprayed they immediately began to migrate from the test site and within 30 minutes were dead. Other tests on L.cuprina eggs resulted in a 100% kill. The product was equally effective against adult flies and showed a 77% kill in 15 minutes rising to 100%
within 30 minutes. Cypermethrin is a broad spectrum insecticide and is effective against other insects, e.g. biting flies, fleas, mosquitoes, and ticks.
RESIDUAL ACTION (of insecticide product)
Residual action tests showed the product was 100% effective after 5 days.Extended field trials demonstrated that the residual action extended well beyond 2 weeks. The product is water soluble and should be re-applied if the animal has been washed or exposed to heavy rain.
DOSAGE AND DIRECTIONS FOR USE
- Use only as directed.
- Remove all organic material and clean the wound using a concentration
of 1:250 of F10 Antiseptic Solution (Concentrate) or F10 Antiseptic
Solution (RTU). Once a day apply a layer of F10 GERMICIDAL
BARRIER OINTMENT or F10 GERMICIDAL BARRIER OINTMENT
WITH INSECTICIDE over the total wound site. Repeat daily or as
directed by the veterinarian taking care to repeat the cleaning
procedure before each application. - Re-occurring conditions should be treated in conjunction with a complete
treatment plan, including antibiotics, as directed by the veterinarian. - A recommended infection control programme for use in cases of
contagious skin infections is shown overleaf. - Replace cap after use.
TOXICOLOGY
Acute toxicity studies were carried out in accordance with the test requirements as specified by the EPA. All studies were subject to an independent GLP compliance audit.
| Toxicity Test | F10 Germicidal Barrier Ointment |
F10 Germicidal Barrier Ointment with Insecticide |
| Acute Oral Toxicity (rats) OPPTS 870.1100 | More than 5000mg/kg – EPA Category IV | 2000 to 5000mg/kg – EPA Category III |
| Acute Dermal Toxicity (rats) OPPTS 870.1200 | More than 5000mg/kg – EPA Category IV | More than 5000mg/kg – EPA Category IV |
| Acute Dermal Irritation (guinea pigs) OPPTS 870.2500 | No dermal irritation – EPA Category IV | Very slight erythema (grade 1) for a few hrs but reversible within 24 hrs – EPA Category IV |
| Toxicity Test | F10 Germicidal Barrier Ointment |
F10 Germicidal Barrier Ointment with Insecticide |
| Acute Eye Irritation (rabbits) OPPTS 870.2400 |
No eye irritation – EPA Category IV |
After 24hrs contact the cornea and iris showed no reaction. The nictitating membranes were graded 1 after 1 hour and were reversible after 72hrs – EPA Category IV |
| Skin Sensitisation (guinea pigs) OPPTS 870.2600 |
No skin sensitization | No skin sensitization |
STABILITY
Shelf life of 2 years.
PRECAUTIONS
- Ingestion: DO NOT induce vomiting. Give milk or water to drink.
- Eye contact: Rinse eyes with water, seek medical advice if necessary.
WARNINGS
- Do not mix with soaps and other chemicals.
- Avoid contact with eyes.
- Keep out of reach of children, uninformed persons and pets.
- • Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder
- Do not use F10 Germicidal Barrier Ointment with Insecticide product on domestic cats.
- Cypermethrin is dangerous to fish or aquatic life. Do not contaminate aquaria, fish bowls, ponds or waterways with the insecticidal product.
IDENTIFICATION
F10 GERMICIDAL BARRIER OINTMENT Semi-solid opaque ointment with a slight natural odour F10 GERMICIDAL BARRIER OINTMENT WITH INSECTICIDE Semi-solid opaque ointment with a pale pink colouring
PRESENTATION
As a semi-solid ointment in 25g tubes, 100g and 500g pots.
STORAGE INSTRUCTIONS
Store below 30ºC in dry conditions.
RECOMMENDATIONS FOR USE IN CASES OF CONTAGIOUS SKIN INFECTIONS
| APPLICATION | FREQUENCY | DILUTION/10 LITRES | MINIMUM EXPOSURE |
| HOUSING Isolate all diagnosed and visibly infected animals immediately. Infected puppies must be isolated with the mother. |
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| Remove all bedding and equipment (e.g. toys, brushes, water and feed bowls) from cages, floors. |
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| Soak bedding and equipment in F10SC or F10SCXD before washing. Hang to dry / tumble dry. |
Daily | 100 ml | 15 min |
| Wash water and feed bowls with warm water and F10SCXD, spray with F10SC and leave to dry. | Daily | 100 ml | Leave to dry |
| Wash all surfaces (work benches, floors, tables, walls, tiles) with F10SCXD. | Daily | 100 ml | Leave to dry |
| STAFF Handling of animals should be limited and involve as few people as possible. |
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| Staff movement must be restricted to designated areas. | |||
| Infected animals and areas should be handled last to avoid cross-contamination. | |||
| Protective clothing should be worn and discarded or washed and disinfected with F10SC or F10SCXD daily. | Daily | 100 ml | Soak 15 min, hang to dry |
| Proper hand decontamination (running water, F10 antiseptic Liquid Soap and paper towel to dry or use F10 Hand Gel) must be done after any animals or possibly infected material such as bedding had been handled. | In between handling animals | 4 ml as is | 30 sec |
| GENERAL Grass should be kept short and exposed to as much sun as possible. |
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| Carrier boxes must be washed (F10SCXD) and disinfected (F10SC) after every use and left to dry. | After every use | 100 ml | Leave to dry |
| All cleaning equipment (mops, cloths, brushes) must be washed with F10SCXD and disinfected with F10SC at the end of each day. | At the end of each shift | 100 ml | Hang to dry |
| ANIMAL TREATMENT
Wash ALL animals immediately with F10 Germicidal Treatment Shampoo to prevent the disease from spreading. |
As is | Leave 15 min rinse | |
| Repeat for up to 3 treatments on every other day on infected animals and once a week on non-infected animals. | As is | Leave 15 min rinse | |
| Apply F10 Germicidal Barrier Ointment to affected lesions once daily. Remove all organic material and ointment using an approved irrigation solution before re-applying the ointment. | Every other day or as prescribed by veterinarian | As is | Leave to dry |