F10: Product Information

F10- benzalkonium chloride and biguanide ointment
Health and Hygiene (Pty) Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Warnings

Not for use in humans. Keep out of reach of children

Uses

For the treatment of mild and localized cases of bumblefoot.

For the use as a topical antiseptic for:

-severe cases of bumblefoot

Surface wounds

Direction of 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 adviced by veterinarian.

Packaging Label

Front Panel

US222-10 20 Antiseptic Barrier ointment 100g FP.jpg

Front Panel
(click image for full-size original)

Packaging Label

Back Panel

US222-10 20 Antiseptic Barrier ointment 100g BP.jpg

Back Panel
(click image for full-size original)
F10
f10 antiseptic barrier ointment ointment
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86152-0091
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.4 g in 100 g
BIGUANIDE (BIGUANIDE) BIGUANIDE 0.03 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86152-0091-1 100 g in 1 JAR None
2 NDC:86152-0091-5 500 g in 1 JAR None
3 NDC:86152-0091-2 25 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
legally marketed unapproved new animal drugs for minor species MIF900009 11/16/2011
Labeler — Health and Hygiene (Pty) Ltd (636762007)
Establishment
Name Address ID/FEI Operations
Health and Hygiene (Pty) Ltd 636762007 manufacture
Establishment
Name Address ID/FEI Operations
Lonza Group AG 480007517 api manufacture

Revised: 01/2022 Health and Hygiene (Pty) Ltd

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