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  5. 508 Compliant Description of The Label for F10® brand Antiseptic Solution
  1. Development & Approval Process

508 Compliant Description of The Label for F10® brand Antiseptic Solution

200 ml Bottle

The top panel contains a caution statement as follows:

Caution: For External Animal Use Only
This product is not to be used in animals intended for use as food for humans or other animals. Use of this product is prohibited in dogs, cats, and horses and in food-producing species such as cattle, pigs, chickens, turkeys, rabbits, deer, ducks, pigeons, and turtles.

The main panel includes the product name and formulation in a large font:

F10® Antiseptic brand Solution
Benzalkonium chloride and Polyhexanide topical solution

Concentrate

The next panel displays the following text:
A broad spectrum topical antiseptic solution

The next panel contains the following disclaimer:

NOT APPROVED BY THE FDA
Legally marketed as an FDA Indexed Product under MIF 900-007. Extra-label use is prohibited. It is a violation of Federal law to use this product in a manner other than as directed on the labeling. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

The bottom panel on the front label contains the following information:

Store between 15 - 30ºC (59º to 86º F) in dry conditions 200 ml

The back label contains the following text:

Description:
The active ingredients in F10® brand Antiseptic Solution are Benzalkonium chloride and Polyhexanide. Benzalkonium chloride is a biocide of the quaternary ammonium group. Its chemical name is: N-Alkyl-N-benzyl-N,N-dimethylammonium chloride. Polyhexanide is a cationic biocide. Its chemical name is: Poly (hexamethylene biguanide hydrochloride). Each mL of F10® brand Antiseptic Solution contains 54.0 mg of benzalkonium chloride and 4.0 mg of polyhexanide.

Indications:
For the treatment and control of upper and lower respiratory tract disease associated with bacterial, fungal, or viral organisms susceptible to benzalkonium chloride and polyhexanide in raptors, pet birds, captive small mammals, and captive reptiles.

For use as a topical antiseptic for surface wounds on raptors, pet birds, captive small mammals, captive reptiles, and captive exotic/zoo mammals.

Use only when there is a reasonable certainty that the treated animal will not be consumed by humans or food-producing animals.

Dosage and Administration:
Dilute the concentrate 1:250 with normal saline solution prior to use.

Nebulization:

  • To Nebulize the glottis, trachea, lungs and air sacs for individual birds, reptiles and small mammals use a chamber connected to a nebulizing unit capable of producing a particle size smaller than 5μm but which allows the resulting “fog” to build-up inside the chamber within 5 minutes and continue for 20 to 40 minutes. Repeat 2 times a day for 2 to 4 weeks (up to 8 weeks in severe cases) until the signs of illness resolve. In raptors, withhold food for 3 hours after nebulization as crop emptying may be delayed.
  • For larger animals or groups of small animals, place them in a suitable sized enclosed room in which a standing fog can be achieved in 5 minutes using a portable electrical atomizer/fogger or a static pressure system capable of producing a particle size of ± 10 to 12μm. Repeat 2 times a day for 2 to 4 weeks (up to 8 weeks in severe cases) until the signs of illness resolve.

Nasal and Sinus Flushing:

  • To remove accumulated mucous and inflammatory material in the upper respiratory tract, syringe into the nasal and sinus cavities (consisting of the external nares, operculum, nasal concha, infraorbital sinus and choanal slit) with the animal’s head down and mouth open to avoid aspiration and allow drainage out of the oral cavity. This treatment should be repeated daily for 10-14 days until the signs of illness resolve.

Surface Wounds:

  • For wound irrigation flush as necessary. For skin decontamination apply as a wash or spray and allow to air dry.

Contraindications:
Do not use with soaps or other chemicals

Warnings:
Not for use in humans. Keep out of reach of children.
If accidentally ingested, do not induce vomiting. Give milk or water to drink.
If accidental eye contact, hold eye open and rinse with water for 10 minutes.
Seek medical help if necessary.

Effectiveness:
The active ingredients Benzalkonium chloride and Polyhexanide act on the cell membrane causing it to rupture, resulting in the loss of essential cell components. Additionally, non-toxic ampholytic surfactants and sequesterants in the drug formulation aid in the penetration of the cell or spore wall. Examples of clinical cases successfully treated with F10® brand Antiseptic Solution include upper respiratory tract disease associated with Pseudomonas spp. and Aspergillus spp. in birds, upper respiratory tract disease associated with Pasteurella spp., Pseudomonas spp., Aspergillus spp. and Mycoplasma spp. in small mammals, acute pneumonia and aspiration pneumonia in neonatal mammals, and upper and lower respiratory tract disease associated with Proteus mirabillis, Pseudomonas aeruginosa, Aeromonas spp. and Mycoplasma spp. in reptiles. All resulted in positive outcomes.

To obtain product information, including Material
Safety Data Sheets (MSDS) e-mail: info@f10products.com  

Manufactured by:
Health and Hygiene (Pty) Ltd
Cnr. Leader & Hoefsmid Streets, Stormill Ext. 10
South Africa
Tel: +27 11 474 1668
www.healthandhygeine.co.za
To report a suspected adverse reaction
e-mail: info@f10products.com
Adverse reactions may also be reported to the FDA/CVM at 1-888-FDA-VETS or
http://www.fda.gov/AnimalVeterinary/SafetyHealth

The bottom right hand corner of the label contains a barcode.

There is a panel across the very bottom of the label that includes a place to insert the LOT NO: and the EXP. DATE: It also notes: Label Revision: Dec 2014-8


1L Bottle

The top panel contains a caution statement as follows:

Caution: For External Animal Use Only
This product is not to be used in animals intended for use as food for humans or other animals. Use of this product is prohibited in dogs, cats, and horses and in food-producing species such as cattle, pigs, chickens, turkeys, rabbits, deer, ducks, pigeons, and turtles.

The main panel includes the product name and formulation in a large font:

F10® Antiseptic brand Solution
Benzalkonium chloride and Polyhexanide topical solution

Ready to use

The next panel displays the following text:
A broad spectrum topical antiseptic solution

The next panel contains the following disclaimer:

NOT APPROVED BY THE FDA
Legally marketed as an FDA Indexed Product under MIF 900-007. Extra-label use is prohibited. It is a violation of Federal law to use this product in a manner other than as directed on the labeling. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

The bottom panel on the front label contains the following information:

Store between 15 - 30ºC (59º to 86º F) in dry conditions 1L

The back label contains the following text:

Description:
The active ingredients in F10® brand Antiseptic Solution are Benzalkonium chloride and Polyhexanide. Benzalkonium chloride is a biocide of the quaternary ammonium group. Its chemical name is: N-Alkyl-N-benzyl-N,N-dimethylammonium chloride. Polyhexanide is a cationic biocide. Its chemical name is: Poly (hexamethylene biguanide hydrochloride). Each mL of F10® brand Antiseptic Solution contains 0.22 mg of benzalkonium chloride and 0.02 mg of polyhexanide.

Indications:
For the treatment and control of upper and lower respiratory tract disease associated with bacterial, fungal, or viral organisms susceptible to benzalkonium chloride and polyhexanide in raptors, pet birds, captive small mammals, and captive reptiles.

For use as a topical antiseptic for surface wounds on raptors, pet birds, captive
small mammals, captive reptiles, and captive exotic/zoo mammals.

Use only when there is a reasonable certainty that the treated animal will not be consumed by humans or food-producing animals.

Dosage and Administration: This is a Ready to Use solution

Nebulization:

  • To Nebulize the glottis, trachea, lungs and air sacs for individual birds, reptiles and small mammals use a chamber connected to a nebulizing unit capable of producing a particle size smaller than 5μm but which allows the resulting “fog” to build-up inside the chamber within 5 minutes and continue for 20 to 40 minutes. Repeat 2 times a day for 2 to 4 weeks (up to 8 weeks in severe cases) until the signs of illness resolve. In raptors, withhold food for 3 hours after nebulization as crop emptying may be delayed.
  • For larger animals or groups of small animals, place them in a suitable sized enclosed room in which a standing fog can be achieved in 5 minutes using a portable electrical atomizer/fogger or a static pressure system capable of producing a particle size of ± 10 to 12μm. Repeat 2 times a day for 2 to 4 weeks (up to 8 weeks in severe cases) until the signs of illness resolve.

Nasal and Sinus Flushing:

  • To remove accumulated mucous and inflammatory material in the upper respiratory tract, syringe into the nasal and sinus cavities (consisting of the external nares, operculum, nasal concha, infraorbital sinus and choanal slit) with the animal’s head down and mouth open to avoid aspiration and allow drainage out of the oral cavity. This treatment should be repeated daily for 10-14 days until the signs of illness resolve.

Surface Wounds:

  • For wound irrigation flush as necessary. For skin decontamination apply as a wash or spray and allow to air dry.

Contraindications: Do not use with soaps or other chemicals

Warnings:
Not for use in humans. Keep out of reach of children.
If accidentally ingested, do not induce vomiting. Give milk or water to drink.
If accidental eye contact, hold eye open and rinse with water for 10 minutes.
Seek medical help if necessary.

Effectiveness:
The active ingredients Benzalkonium chloride and Polyhexanide act on the cell membrane causing it to rupture, resulting in the loss of essential cell components. Additionally, non-toxic ampholytic surfactants and sequesterants in the drug formulation aid in the penetration of the cell or spore wall. Examples of clinical cases successfully treated with F10® brand Antiseptic Solution include upper respiratory tract disease associated with Pseudomonas spp. and Aspergillus spp. in birds, upper respiratory tract disease associated with Pasteurella spp., Pseudomonas spp., Aspergillus spp. and Mycoplasma spp. in small mammals, acute pneumonia and aspiration pneumonia in neonatal mammals, and upper and lower respiratory tract disease associated with Proteus mirabillis, Pseudomonas aeruginosa, Aeromonas spp. and Mycoplasma spp. in reptiles. All resulted in positive outcomes.

To obtain product information, including Material Safety Data Sheets (MSDS)
e-mail: info@f10products.com

Manufactured by:
Health and Hygiene (Pty) Ltd
Cnr. Leader & Hoefsmid Streets,
Stormill Ext. 10
South Africa
Tel: +27 11 474 1668
www.healthandhygiene.co.za

To report a suspected adverse reaction
e-mail:
info@f10products.com
Adverse reactions may also be reported to the FDA/CVM at 1-888-FDA-VETS or
http://www.fda.gov/AnimalVeterinary/SafetyHealth

The bottom right hand corner of the label contains a barcode.

There is a panel across the very bottom of the label that includes a place to insert the LOT NO: and the EXP. DATE: It also notes: Label Revision: Dec 2014-9