Label: PROVITA HOOFSURE ENDURANCE EXPRESS- formic acid solution, concentrate
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NDC Code(s):
16371-107-01,
16371-107-02,
16371-107-03,
16371-107-04, view more16371-107-05
- Packager: Provita Eurotech Ltd
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated August 14, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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VETERINARY INDICATIONS
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.
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
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PRECAUTIONS
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.
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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 Capacity Number 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 gals Up to 250 50 gals Up 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 Capacity Number 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).
25gal Up to 500 50 gal 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 sprayer, apply to the hoof.
- PRINCIPAL DISPLAY PANEL - 4.75 Litre Drum Label
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INGREDIENTS AND APPEARANCE
PROVITA HOOFSURE ENDURANCE EXPRESS
formic acid solution, concentrateProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:16371-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1) FORMIC ACID 608 g in 1 L Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16371-107-01 4.75 L in 1 DRUM 2 NDC:16371-107-02 19 L in 1 DRUM 3 NDC:16371-107-03 57 L in 1 DRUM 4 NDC:16371-107-04 114 L in 1 DRUM 5 NDC:16371-107-05 209 L in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 04/21/2023 Labeler - Provita Eurotech Ltd (238318232) Establishment Name Address ID/FEI Business Operations Provita Eurotech Ltd 220688192 MANUFACTURE, PACK, LABEL, ANALYSIS, API MANUFACTURE
