PROVITA HOOFSURE ENDURANCE EXPRESS- formic acid solution, concentrate 
Provita Eurotech 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.

----------

Provita Hoofsure Endurance Express

Management Information

Hoofsure Endurance Express is a scientifically proven proprietary blend of organic acids, essential oils and wetting agents specifically designed and formulated to both clean and care for hooves. It does not contain copper, formaldehyde or antibiotics. Hoofsure Endurance Express is intended for use as part of a hoof maintenance program in conjunction with your veterinarian. Hoof health is dependent on good nutrition, hygiene, management and herd health care. Footbathing is a control measure and not a treatment. To optimize hoof health, a treat and control protocol is recommended. Lame cows should be identified, footbathed regularly and treated with an appropriate product such as Provita Konquest gel and Provita Combat spray.

Ingredients

Organic Acids (Acetic and Formic), Water, Ethanol, Alkoxylated Cetyl Alcohol, Laureth-4, Tea-tree Oil, E124, E133.

Disposal

Hoofsure Endurance Express is not subject to bioaccumulation. After use, spent footbath can be disposed of by landfill or flushing to a slurry lagoon in accordance with local regulations. Not for human use.

Precautions

Danger: Flammable liquid and vapour. Harmful if swallowed. Causes severe skin burns and eye damage. Keep away from heat/ sparks/open flames/hot surfaces — No smoking. Do not breathe dust / fume / gas / mist / vapours / spray. Wear protective gloves/ protective clothing/eye protection/face protection. IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/ shower. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do, continue rinsing. If symptoms persist, immediately call a POISON CENTER or doctor/physician. In case of fire: Use water, carbon dioxide (CO2), foam, dry powder for extinction. Store in a well-ventilated place. Keep cool. Keep out of reach of children. For animal use only. Do not use in galvanised footbaths.

Directions for Use

Dairy Cattle

For footbath use: For optimum results footbath at every milking, every day. Mix Hoofsure Endurance Express 1:100 (equivalent to a 1% solution - e.g. half gallon of Hoofsure Endurance Express with 50 gal clean water in a 50 gal footbath). When required, a 2% or above dilution rate may be used. Place footbath in return alley, not in parlor. Wash dirt and manure off feet prior to walking through the footbath. Ideally, use a pre-wash bath.

Number of cow passes before filling fresh footbath (approximate):
Footbath CapacityNumber of Cow Passes*
*
Ensure footbath solution is at 5" depth or above at all times. Check depth of solution every 200 cows and top up, as necessary, using a top up solution (mix ½ gallon of Hoofsure Endurance Express with 5 gallons of water and add to the footbath. Use of heavily soiled footbaths can become a source of infection or re-infection.
25 galsUp to 250
50 galsUp to 500
100 gals Up to 1000

For topical application: After inspection or trimming, administer a 25% solution of Hoofsure Endurance Express (i.e. 4 oz Provita Hoofsure Endurance Express mixed with 20 oz of clean water). Using a sprayer, apply to the hoof once per day for up to 3 weeks.

Beef cattle

For footbath use: Footbath every 4-6 weeks. Mix Hoofsure Endurance Express 5:100 (equivalent to a 5% solution - e.g. 5 gallons of Hoofsure Endurance Express with 100 gal clean water in a 100 gal footbath). Wash dirt and manure off feet prior to walking through the footbath. A 100 gal footbath can have 1000 cow passes before needing filled fresh.

Ensure footbath solution is at 5" depth or above at all times. Check depth of solution every 200 cows and top up, as necessary, using a top up solution (mix ½ gallon of Hoofsure Endurance Express with 5 gallons of water and add to the footbath. Use of heavily soiled footbaths can become a source of infection or re-infection.

For topical application: After inspection or trimming, administer a 25% solution of Hoofsure Endurance Express (i.e. 4 oz Provita Hoofsure Endurance Express mixed with 20 oz of clean water). Using a sprayer, apply to the hoof.

Sheep

For footbath use: Footbath every 2-4 weeks. Mix Hoofsure Endurance Express 1:100 (equivalent to a 1% solution - e.g. half gallon of Hoofsure Endurance Express with 50 gal clean water in a 50 gal footbath). When required, a 2% dilution rate may be used. Walk sheep through footbath 3 times or allow sheep to stand in the solution for a short period. A 50 gal footbath can have up to 1000 sheep passes before needing filled fresh.

Number of sheep passes before filling fresh footbath (approximate):
Footbath CapacityNumber of Sheep Passes*
*
Ensure footbath Express solution is at 3" depth or above at all times. Check depth of solution every 100 sheep and top up, as necessary, using a top up solution (mix ½ gallon of Hoofsure Endurance Express with 5 gallons of water and add to the footbath).
25galUp to 500
50 galUp to 1000

For topical application: After inspection or trimming, administer a 25% solution of Hoofsure Endurance Express (i.e. 4 oz Provita Hoofsure Endurance Express mixed with 20 oz of clean water). Using sprayer, apply to the hoof.

PRINCIPAL DISPLAY PANEL - 4.75 Litre Drum Label

Provita
Animal Health Naturally

Hoofsure
Endurance
EXPRESS
A footbath solution for healthy hooves
and to aid in the control of footrot

NEW
IMPROVED
FORMULA
33% FASTER ACTING

FOR UP TO
2000
SHEEP,
1250
COWS

PRINCIPAL DISPLAY PANEL - 4.75 Litre Drum Label
PROVITA HOOFSURE ENDURANCE EXPRESS 
formic acid solution, concentrate
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:16371-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1) FORMIC ACID608 g  in 1 L
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16371-107-014.75 L in 1 DRUM
2NDC:16371-107-0219 L in 1 DRUM
3NDC:16371-107-0357 L in 1 DRUM
4NDC:16371-107-04114 L in 1 DRUM
5NDC:16371-107-05209 L in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/21/2023
Labeler - Provita Eurotech Ltd (238318232)
Establishment
NameAddressID/FEIBusiness Operations
Provita Eurotech Ltd220688192MANUFACTURE, PACK, LABEL, ANALYSIS, API MANUFACTURE

Revised: 8/2023
Document Id: a11f62d6-5e80-4bce-b4b8-641e1c1a6755
Set id: e86db6a8-2745-4951-89c2-ef5b5c76c247
Version: 2
Effective Time: 20230814
 
Provita Eurotech Ltd