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  5. 508 Compliant Description of the Label for F10® brand Antiseptic Barrier Ointment
  1. Development & Approval Process

508 Compliant Description of the Label for F10® brand Antiseptic Barrier Ointment

508 Compliant Description of the Label for F10® brand Antiseptic Barrier Ointment

25g Tube

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 Barrier Ointment
(Benzalkonium chloride and Polyhexanide topical ointment)

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

A BROAD SPECTRUM TOPICAL ANTISEPTIC OINTMENT

NOT APPROVED BY THE FDA
Legally marketed as an FDA Indexed Product under MIF 900-009. 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 15º - 30ºC (59º to 86º F) in dry conditions 25 g

The back label contains the following text:

There is a line across the very top of the label that includes a place to insert the LOT NO: and the EXP. DATE:

Uses:
For the treatment of mild and localized cases of bumblefoot (pododermititis) in caged raptors and pet birds.

For use as a topical antiseptic for:

  • more severe cases of bumblefoot to assist healing after surgery in caged raptors and pet birds.
  • 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.

Do not use: Do not use with soaps or other chemicals.

Human 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 attention if necessary.

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

Directions for Use:
Clean the wound prior to application. Apply a layer of ointment over the entire wound site once a day. Repeat daily until wound is healed or as advised by your veterinarian. If the wound does not show signs of healing after 5 days or worsens, contact your veterinarian.

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 and notes: Label revision: Nov 2014-3


100g Jar

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 Barrier Ointment
(Benzalkonium chloride and Polyhexanide topical ointment)

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

A BROAD SPECTRUM TOPICAL ANTISEPTIC OINTMENT

NOT APPROVED BY THE FDA
Legally marketed as an FDA Indexed Product under MIF 900-009. 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 15º - 30ºC (59º to 86º F) in dry conditions Net contents: 100 g

The back label contains the following text:

Uses:
For the treatment of mild and localized cases of bumblefoot (pododermititis) in caged raptors and pet birds.

For use as a topical antiseptic for:

  • more severe cases of bumblefoot to assist healing after surgery in caged raptors and pet birds.
  • 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.

Do not use: Do not use with soaps or other chemicals.

Human 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.

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

Directions for Use:
Clean the wound prior to application. Apply a layer of ointment over the entire wound site once a day. Repeat daily until wound is healed or as advised by your veterinarian. If the wound does not show signs of healing after 5 days or worsens, contact your veterinarian.

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

There is a line 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: Nov 2014-3

The edge of the label contains a barcode.


500g Jar

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 Barrier Ointment
(Benzalkonium chloride and Polyhexanide topical ointment)

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

A BROAD SPECTRUM TOPICAL ANTISEPTIC OINTMENT

NOT APPROVED BY THE FDA
Legally marketed as an FDA Indexed Product under MIF 900-009. 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 15º - 30ºC (59º to 86º F) in dry conditions Net contents: 500 g

The back label contains the following text:

Uses:
For the treatment of mild and localized cases of bumblefoot (pododermititis) in caged raptors and pet birds.

For use as a topical antiseptic for:

  • more severe cases of bumblefoot to assist healing after surgery in caged raptors and pet birds.
  • 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.

Do not use: Do not use with soaps or other chemicals.

Human 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.

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

Directions for Use:
Clean the wound prior to application. Apply a layer of ointment over the entire wound site once a day. Repeat daily until wound is healed or as advised by your veterinarian. If the wound does not show signs of healing after 5 days or worsens, contact your veterinarian.

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

There is a line 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: Nov 2014-3

The edge of the label contains a barcode.