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  5. 508 Compliant Description of the Label for F10® brand Antiseptic Wound Spray with Insecticide
  1. Development & Approval Process

508 Compliant Description of the Label for F10® brand Antiseptic Wound Spray with Insecticide

100 ml

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® brand Antiseptic Wound Spray with Insecticide

(Benzalkonium chloride and Polyhexanide and Cypermethrin topical solution)

Ready to use

 Active Ingredients  Purpose
 
 Benzalkonium Chloride 0.405g/100mL  Antiseptic
 
 Polyhexanide 0.03g/100mL  Antiseptic
 
 Cypermethrin 0.25g/100g  Insecticide

A broad spectrum topical antiseptic spot treatment with Insecticide

NOT APPROVED BY THE FDA
Legally marketed as an FDA Indexed Product under MIF 900-010.
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.

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

Store between 15 - 30ºC (59º to 86º F) in dry conditions 100 ml

The back label contains the following text:

Uses:
For use as a topical antiseptic for surface wounds, to repel flies and to treat infestations due to fly strike in 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.

Do not use: Do not use with soaps or other chemicals.
This product is extremely toxic to fish, aquatic invertebrates, oysters and shrimp. Do not apply directly to or near water.

Human Warnings:
Not for use in humans.
Keep out of reach of children.
Do not contaminate food, water, eating utensils, or food contact surfaces. Wash hands before eating or drinking.
If accidentally ingested, contact a Poison Control Center or a doctor.
Do not induce vomiting unless advised by the Poison Control Center or a doctor.
If accidental eye contact, hold eye open and rinse with water for 10 minutes.
Seek medical help if necessary.
Avoid breathing of spray mist.

To obtain product information, including material safety data sheets (MSDS)
e-mail: info@f10products.com

Directions for Use:
Use disposable gloves during application and wash hands thoroughly after use.
Use only in well ventilated areas.
Clean the wound prior to application. Apply a maximum of 5 applications per animal with multiple wounds (1-2 sprays per wound). Spray only the wound site. Repeat once a week, if necessary or as advised by your veterinarian.
This product is water soluble and should be reapplied if animal is bathed or exposed to rain. If the wound persists or worsens, contact your veterinarian.

Disposal:
Do not reuse container. If empty, place in trash or recycle if available. If partly filled, contact your local solid waste agency for disposal instructions.

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: Jan 2015

 


 

500 ml Size


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® brand Antiseptic Wound Spray with Insecticide
(Benzalkonium chloride and Polyhexanide and Cypermethrin topical solution)

Ready to use

 Active Ingredients  Purpose
 
 Benzalkonium Chloride 0.405g/100mL  Antiseptic
 
 Polyhexanide 0.03g/100mL  Antiseptic
 
 Cypermethrin 0.25g/100g  Insecticide

A broad spectrum topical antiseptic spot treatment with Insecticide

NOT APPROVED BY THE FDA
Legally marketed as an FDA Indexed Product under MIF 900-010.
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.

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

Store between 15 - 30ºC (59º to 86º F) in dry conditions 500 ml

The back label contains the following text:

Uses:
For use as a topical antiseptic for surface wounds, to repel flies and to treat infestations due to fly strike in 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.

Do not use: Do not use with soaps or other chemicals. This product is extremely toxic to fish, aquatic invertebrates, oysters and shrimp. Do not apply directly to or near water.

Human Warnings:
Not for use in humans.
Keep out of reach of children.
Do not contaminate food, water, eating utensils, or food contact surfaces. Wash hands before eating or drinking.
If accidentally ingested, contact a Poison Control Center or a doctor.
Do not induce vomiting unless advised by the Poison Control Center or a doctor.
If accidental eye contact, hold eye open and rinse with water for 10 minutes.
Seek medical help if necessary.
Avoid breathing of spray mist.

To obtain product information, including material safety data sheets (MSDS)
e-mail: info@f10products.com

Directions for Use:
Use disposable gloves during application and wash hands thoroughly after use.
Use only in well ventilated areas.
Clean the wound prior to application. Apply a maximum of 5 applications per animal with multiple wounds (1-2 sprays per wound). Spray only the wound site. Repeat once a week, if necessary or as advised by your veterinarian.
This product is water soluble and should be reapplied if animal is bathed or exposed to rain. If the wound persists or worsens, contact your veterinarian.

Disposal:
Do not reuse container. If empty, place in trash or recycle if available. If partly filled, contact your local solid waste agency for disposal instructions.

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: Jan 2015