Proactive 1.52 mg/ml Teat Dip/Spray Solution
Iodine
Last verified
Veterinary medicinal product: teat dip/spray solution. Distribution category: AVM-GSL (Veterinary Medicines Regulations 2013, Schedule 3). Active substance: Iodine.1
In short: questions and answers
- Does Proactive 1.52 mg/ml Teat Dip/Spray Solution need a prescription?
- Over the counter. As stated in the registration decision.1
- Which animals is Proactive 1.52 mg/ml Teat Dip/Spray Solution for?
- Cattle.1
- What is the active substance in Proactive 1.52 mg/ml Teat Dip/Spray Solution?
- Iodine. ATCvet code: QD08AG03.13
- What is the withdrawal period of Proactive 1.52 mg/ml Teat Dip/Spray Solution according to the leaflet?
- Cattle, meat: 0 days; Cattle, milk: 0 days.3
- Dispensing
- Over the counter1
AVM-GSL: Authorised Veterinary Medicine - General Sale List. No prescription is needed and it may be sold by any retailer.12
Supplied without a prescription. As stated in the registration decision.
- Animal species
- Cattle1
- Active substance
- Iodine
- ATCvet code
- QD08AG033
- Manufacturer
- Marketing authorisation holder: DeLaval NV
Withdrawal period
Summary of product characteristics
Composition
One mL contains :
Active substance:
Iodine 1.52 mg
Excipients:
| Qualitative composition of excipients and other constituents |
|---|
| Citric acid monohydrate |
| Glycerol |
| Sodium iodate |
| Sodium chloride |
| Sodium hydroxide |
| Sorbitol, liquid (non-crystallising) |
| Xanthan Gum |
| Sodium iodide |
| Poloxamer 335 |
| Polysorbate 80 |
| Purified water |
A red-brown liquid.
Pharmacological properties
4.1 ATCvet code:
QD08AG03
4.2 Pharmacodynamics
The veterinary medicinal product is an antiseptic. The active form of this product is the free (molecular) iodine.
The mechanism of kill appears to be due to an oxidative reductive reaction, involving various cell wall constituents, which are irreversibly transformed. It appears sulfhydryl linkages, in bacteria cell wall components, are specifically targeted by the iodine. The veterinary medicinal product has been tested according to European Standards EN 1040 and EN 1656 against:
Pseudomonas aeruginosa
Staphylococcus aureus
Enterococcus hirae
Proteus vulgaris
4.3 Pharmacokinetics
Literature suggests that absorption of iodine through the skin is well below levels which would lead to pharmacokinetic activity in the body.
Target species
Cattle (dairy cows).
Indications
Teat disinfection as part of a strategy to reduce the incidence of mastitis in lactating cattle (mastitis prophylaxis).
Dosage
Teat use.
Amounts to be administered: 5 ml per cow per application.
The veterinary medicinal product is meant to be used as a post-milking teat dip or spray up to two times per day. The duration of treatment is not limited.
Dip each teat of the cow immediately after milking in a dip cup containing undiluted veterinary medicinal product. Alternatively, spray the entire teats after each milking. Spraying must be done from below the teat. Ensure that the teat is covered to three quarters length and replenish the dip cup or spray container as necessary. The dip cup or spray container should be emptied after each milking and washed before reuse.
Ensure udder and teats are clean and dry before each milking.
If the veterinary medicinal product has frozen, thaw in a warm room and shake well before use.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Adverse reactions
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the label for respective contact details.
Warnings
Special precautions for safe use in the target species:
For external use only. Use in injured teats may delay wound healing process. It is recommended that treatment be discontinued until teat lesions have resolved. Allow the veterinary medicinal product to dry before the cows are exposed to rain, cold or windy weather conditions
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known hypersensitivity to iodine or to any of the excipients should avoid contact with the veterinary medicinal product. If you develop symptoms following exposure, such as skin rash you should seek medical advice and show the combined package leaflet and label to the physician.
Avoid ingesting the veterinary medicinal product. In case of accidental ingestion seek medical advice immediately and show the combined package leaflet and label to the physician.
Do not eat, drink or smoke while using the veterinary medicinal product. When used as spray, avoid working in spray mist. This veterinary medicinal product might be mildly irritating to skin and eyes. Avoid contact with skin and eyes when administering the veterinary medicinal product. During application avoid contact with hands or wear protective gloves. If the veterinary medicinal product comes into contact with the eyes, rinse immediately with plenty of water.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interactions
The veterinary medicinal product must not be used concurrently with other teat disinfectants or care products.
Overdose
Not applicable, veterinary medicinal product is for topical application, significant absorption does not occur.
Special warnings
The presence of milk or dirt neutralizes iodine, reducing its activity and effectiveness. Ensure that the udder and teats are clean and dry before the next milking.
Withdrawal period
Meat and offal: Zero days.
Milk: Zero hours.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products or alkalis or reducing substances.
Immediate packaging
Opaque high-density polyethylene barrel of 5, 10, 20, 60 or 200 litre, with high-density polyethylene screw caps. Not all pack sizes may be marketed.
Storage
Do not store above 25 °C.
Store upright in the tightly closed original container.
Protect from frost.
Protect from light.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 30 months. Shelf life after first opening the immediate packaging: 1 year.
Disposal of unused product
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Medicines should not be disposed of via wastewater or household waste.
The veterinary medicinal product should not enter water courses as iodine may be dangerous for fish and other aquatic organisms.
Additional information
Vm 17140/3001
Vm 17140/5001
8 DATE OF FIRST AUTHORISATION
05 July 2000
9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
July 2025
10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT
Veterinary medicinal product not subject to prescription.
Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.
Approved: 11 August 2025
Registration holder
DeLaval NV
Regulations
- Veterinary Medicines Regulations 2013 (SI 2013/2033), Schedule 32
Sources
- VMD Product Information Database: Proactive 1.52 mg/ml Teat Dip/Spray Solution, 17140/5001
- The Veterinary Medicines Regulations 2013, Schedule 3 (categories of veterinary medicinal products)
- Summary of Product Characteristics: Proactive 1.52 mg/ml Teat Dip/Spray Solution
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