Teat Antiseptic Product Monograph

Table of Contents

1. Foreword

This Monograph describes the requirements necessary to receive market authorization for teat antiseptic products, such as teat dips. The Monograph outlines the permissible conditions of use and labelling requirements such as intended use, directions for use, warnings, medicinal (active) ingredients, emollients and combinations thereof. The Monograph has been developed for teat antiseptic products that have a well characterized safety and efficacy profile under specific conditions of use.

When the product and its labelling are consistent with the information set out in the Monograph, a sponsor / manufacturer may reference the Monograph in the cover letter of a Drug Identification Number (DIN) submission and the product may be considered as a Not New Drug under Division 1 of the Food and Drug Regulations. For more information please refer to Appendix 1: DIN submission package requirements.

When the product or its labelling falls outside the scope of this Monograph, a classification template should be requested from classification.vet@hc-sc.gc.ca for a proper product status decision. The product may be considered as a New Drug subject to Division 8 of the Food and Drug Regulations. If classified as a New Drug, the sponsor / manufacturer will have to submit additional evidence to support the safety, efficacy, and quality of the product when used according to the proposed conditions of use. Examples of these situations include, but are not limited to:

  • ingredient and/or combination of ingredients not provided for in the Monograph;
  • strength and/or directions for use not provided for in the Monograph.

For more information on the New Drug submission process, please refer to Health Canada’s Guidance for Industry - Preparation of Veterinary New Drug submissions.

Please note that all products are subject to Good Manufacturing Practices (GMP) outlined in Part C, Division 2 of the Food and Drug Regulations whether or not the drug submission references a Monograph.

It is important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this Monograph, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

2. Teat Antiseptic Product Monograph

2.1 Pharmaceutical Quality

All ingredients (medicinal and non-medicinal) and finished product specifications should as a minimum meet acceptable quality standards as required by the Food and Drugs Act, or equivalent standards.

2.2 Ingredients

The strengths and combinations of medicinal ingredients and emollients are restricted to those specified in this Monograph.

2.2.1 Medicinal Ingredients

Medicinal ingredients are considered as such when associated with germicidal activity at the proposed strength, and should be identified on product labelling by the proper/common names provided in Table 1. Some medicinal ingredients cannot be combined with any other medicinal ingredient in a product formulation, while others are only permitted when combined with one or more medicinal ingredient(s) (with or without emollients). The permitted strengths and/or range for all acceptable medicinal ingredients are provided in Table 1.

2.2.2 Non-Medicinal Ingredients

Non-medicinal ingredients should be restricted to the substances (and amounts) that are necessary for the formulation of the particular dosage form. Their concentration should not exceed the minimum required to provide their intended effect. They should not provide any therapeutic effect and should be harmless in the amounts used, their presence should not adversely affect the efficacy or safety of the medicinal ingredients, and they should not interfere with tests for the medicinal ingredients and, if present, antimicrobial preservatives.

Emollients (Conditioning, Moisturizing Agents)

Emollients are considered as such when associated with skin-conditioning activity at the proposed strength, and should be identified on product labelling by the proper/common names provided in Table 2. The permitted strength and/or range for all acceptable emollients are provided in Table 3.

2.2.3 Acceptable Combinations of Medicinal Ingredients with Emollients

Refer to Table 3 for a complete list of acceptable combinations (medicinal ingredients with emollients) within the context of this Monograph.

2.3 Labelling

(Please refer to Appendix 2 for an example of label format – English version)

This Monograph describes the requirements that are specific to this class of drugs. All other labelling requirements described in the Food and Drugs Act and Regulations must be respected.

2.3.1 Description

Brand name: Name assigned by the sponsor / manufacturer and approved by Health Canada in connection with a drug product.

  • (1) A brand name or product description may contain one or more product attribute(s) that can serve as a basis for product identification. Product attributes should refer to the quality of the product and should be measurable, i.e. by reference to the product formulation only. Acceptable product attributes include reference to one or more non-medicinal ingredients (e.g. “XX surfactant” or “with emollients”).
  • (2) Comparison and implied comparison terms used to describe the composition of drug products are not considered acceptable; for example, the terms “high” and “low” generally imply unidentified comparisons and standards against which a drug product must be measured. For teat antiseptics, there are no existing standards in what constitutes “high” and “low” (e.g. concentrations of non-medicinal ingredients or product viscosity); therefore, these terms are unacceptable. Similarly, reference terms that describe the method of application or action of the product on application (e.g. foaming action) are not considered acceptable.
  • (3) When assigning a brand name, please be reminded that subsection 9(1) of the Act prohibits the representation of a drug “in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.”
  • (4) To ensure compliance with regulations, Health Canada reserves the right to request a scientific rationale for any brand name qualifier or product description associated with a formulation or formulation change which could potentially impact the impression of quality, safety and/or efficacy of the product under labelled conditions of use.

    For more information on the use of product attributes, please refer to the Guidance Document: Labelling of Pharmaceutical Drugs for Human Use where this issue was also taken into consideration.

2.3.2 Proper/Common Name

Active ingredient(s) and dosage form

2.3.3 Species

Dairy cattle

2.3.4 Dosage form

Teat Antiseptic Solution (Post-milking or, Pre- and Post-milking)

2.3.5 Route of administration

Topical

2.3.6 Indications

Required statements as applicable:
BRAND NAME is a [post-milking] or [pre- and post-milking] teat antiseptic solution to be used as an aid in reducing the spread of organisms which may cause mastitis in dairy cattle.

2.3.7 Mixing directions for products containing lactic acid and sodium chlorite only

Measure equal volumes of BRAND NAME base and BRAND NAME activator into a clean container and mix until the color is uniform throughout. Do not dilute. Mix only enough product for one milking of the herd. Always use freshly mixed, full strength BRAND NAME.

2.3.8 Directions for use

PRE-MILKING
Required statements:

  • Use at full strength. Do not dilute.
  • Before milking, apply BRAND NAME to each teat, ensuring complete coverage of all teats with the solution. After 15 to 30 seconds, dry each teat thoroughly. If the udder and teats are heavily soiled, clean with an antiseptic udder wash and dry thoroughly before application of BRAND NAME.

POST-MILKING
Required statements:

  • Use at full strength. Do not dilute.
  • Apply BRAND NAME to each teat immediately after milking. Ensure that the solution thoroughly covers the entire surface of all teats. Allow teats to dry. Do not wipe.
  • If outside temperature is below freezing, allow to air dry on the teats before turning cows out to cold weather to prevent freezing. A fresh solution should always be used at each milking. The application equipment should be cleaned and rinsed properly after each milking session or when the solution becomes contaminated. Do not pour remaining solution back into the original container. Keep container closed to prevent contamination of the product.

Optional statements:

When a cow is being dried off, continue the application of BRAND NAME to all teats once daily for 1 to 2 weeks as required after the last milking. With freshening cows, resume application of BRAND NAME to all teats twice daily for 7 to 10 days before calving.

2.3.9 Cautions

Required statements:

For external use only. If cow’s teats are sore, irritated or chapped, consult a veterinarian before starting or continuing to use teat antiseptic.

2.3.10 Warnings

Required statements:
No meat withdrawal period or milk withholding time is required when used according to the label. Avoid contact with food. Do not take internally. If accidentally ingested, drink large volumes of water. Avoid contact with skin and eyes. If accidental contact occurs, flush thoroughly with running water. SeekFootnote 1 medical attention ([immediately] OR [if symptoms occur or persist]) after oral exposure or contact with skin and eyes. Avoid breathing vapours. Do not use for cleaning and/or sanitizing milking equipment. Keep out of reach of children.

2.3.11 Storage conditions

Example (dependent upon product specifications):

Store between X °C and XX °C. Keep from freezing. Store in a cool, dry, clean area. Keep away from direct sunlight and heat to avoid deterioration. Keep container tightly closed.

2.3.12 Additional labelling information

The labelling must be in both official languages. The statement “For Veterinary Use Only” should appear on the principal display (main) panel.

2.4 Specifications

Any changes that may impact the quality, safety and/or efficacy of the product should be reported to the VDD and additional information may be requested, including re-submission of the application as a New Drug.

2.5 Reference Tables

Table 1: Medicinal Ingredients (MI)

Proper/Common name

Acceptable strength or range (%w/w)

Acceptable only as single MI

Acceptable only in combination specified in this Monograph (refer to Table 3)
For Post-Milking Products Only
Chlorhexidine acetate 0.5 – 0.55 Yes N/A
Chlorhexidine gluconate 0.35 – 0.475 Yes N/A
Iodine (titratable) 0.25 – 1 Yes N/A
Linear dodecyl benzene sulfonic acid 1.94 Yes N/A
For Post-milking or, Pre- and Post-milking Products
Hydrogen Peroxide 0.5 N/A Yes
Iodine (titratable) 0.25 - 0.5 Yes N/A
Lactic acid 1.7 - 2.64 N/A Yes
Sodium chlorite 0.64 N/A Yes
Sodium linear alkylate sulfonate 0.5 N/A Yes
Table 2: Emollients (Conditioning, Moisturizing Agents; Non-Medicinal Ingredients)
Proper/Common name
For Post-Milking Products Only
Lanolin
Propylene Glycol
For Post-milking or, Pre- and Post-milking Products

Glycerin

Table 3: Complete List of Acceptable Combinations and Strengths of Medicinal Ingredients (Single or in Combination) and Emollients Footnote *
Medicinal Ingredients (%) Emollients with acceptable strength or range(%)
For Post-Milking Products Only
Chlorhexidine acetate (0.5 –  0.55) Glycerin (0 – 7)
Chlorhexidine gluconate (0.35 –  0.475) Glycerin (2)
Iodine (titratable) (0.25 – 1) Glycerin (0 – 10), Lanolin (0 – 2),
Propylene Glycol (0 – 6) Footnote **
Linear dodecyl benzene sulfonic acid (1.94) Glycerin (3)
For Post-milking or, Pre- and Post-milking Products
Iodine (titratable) (0.25 – 0.5) Glycerin (0 – 5)
Lactic acid (2.64) + Sodium chlorite (0.64) Glycerin (0 – 10)
Lactic acid (1.7) + Hydrogen peroxide (0.5) + Sodium linear alkylate sulfonate (0.5) Glycerin (5)
Table Note 3

Each row represents one product formulation of medicinal ingredient(s) with or without emollient(s)

Return to table note * referrer

For iodine-containing formulations with more than one emollient, the combined strength of emollients should not exceed 10 – 12%.

Return to table note ** referrer

Table 4: List of Admissible Iodine Complexes
Admissible Iodine Complexes
ALKYL PHENOL POLYGLYCOL ETHER - IODINE COMPLEX
HYDRIODIC ACID - IODINE COMPLEX (HI – I2)
NONYL PHENOXY POLYETHOXY ETHANOL - IODINE COMPLEX
POLYALKYLENE GLYCOL ETHER - IODOPHOR COMPLEX
POLYETHOXY POLYPROPOXY POLYETHOXY ETHANOL - IODINE COMPLEX
POLYOXYETHYLENE GLYCOL - IODINE COMPLEX
POLYOXYPROPYLENE/POLYOXYETHYLENE BLOCK COPOLYMER - IODINE COMPLEX

2.6 References

2.6.1
Belsito Jessica. Alternative teat dips: Weighing cost and quality. Progressive Dairyman. August 2012. http://www.progressivedairycanada.com/topics/facilities-equipment/alternative-teat-dips-weighing-cost-and-quality
2.6.2
Health Canada. Drug Product Database Online Query. Search for Teat Dips: Status – All, Class - Veterinary, Route of Administration - Topical, Dosage Form – Solution. Date Modified: 2015-07-17. https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
2.6.3
Health Canada. Guidelines for Evaluation of Safety and Efficacy of Teat Dip Formulations. Date Modified: 2009-11-06. http://www.hc-sc.gc.ca/dhp-mps/vet/legislation/guide-ld/teat_guidelines_trayons_directives-eng.php
2.6.4
National Mastitis Council (NMC). Summary of Peer-Reviewed Publications on Efficacy of Premilking and Postmilking Teat Disinfectants. Published Since 1980 (revised 2014). 14 pages. http://www.nmconline.org/wp-content/uploads/2016/08/EFFICACY-OF-PREMILKING-AND-POSTMILKING-TEAT-DISINFECTANTS.pdf
2.6.5
Nickerson, Stephen C. Choosing the Best Teat Dip for Mastitis Control and Milk Quality. Louisiana State University Agricultural Center, Homer, Louisiana. NMC-PDPW Milk Quality Conference Proceedings (2001). pp. 43-53.  http://www.dairyweb.ca/Resources/USWebDocs/TeatDips.pdf
2.6.6
Pankey, J.W., Eberhardt, R.J., et al. Our Industry Today. Uptake on Postmilking Teat Antisepsis. Journal of Dairy Science, Vol. 67, No. 6, 1984. pp. 1336-1353.
2.6.7
Zoller, Uri. Handbook of Detergents, Part E: Applications. Taylor & Francis Group 2009.  141: 271-277.

i. Appendix 1: DIN Submission Package Requirements

To apply for market authorization for a product subject to Division 1 of the Food and Drugs Regulations, a DIN submission should be filed; the following documentation is required:

  • A cover letter stating the purpose of the submission;
  • An original, signed and dated version of the Drug Submission Application form.
  • Copies of all labelling (package insert, inner labels, outer labels, etc.,) should be submitted in both English and French, in electronic format.  It is preferable to save all labelling components and package sizes in one MS Word document. If available, mock-up of labels can be submitted. In addition, please provide an attestation to the complete and accurate translation of the French version of the labelling.  Kindly ensure that a version date is included in the footer of each page. 
  • The applicable fee of $720 and the Veterinary Drug Submission Fee Application form.

The Veterinary Drugs Directorate (VDD) is now operating in a fully electronic environment.  Please refer to the following Guidance Document: Preparation of Drug Regulatory Activities in “Non-eCTD Electronic-Only” Format.

The submission can be sent to skmd-so_dgps-cp@hc-sc.gc.ca in one single email with attachments, provided that the total attachments are less than 10 megabytes. If it does not meet these criteria, please submit the electronic documents via courier. A paper copy is no longer required.

ii. Appendix 2: Example of label format (English version)

Net: XX L

DIN XXXXXXXX

Veterinary use only

BRAND NAME:

CHLORHEXIDINE ACETATE POST MILKING TEAT ANTISEPTIC SOLUTION

WARNINGS:

No meat withdrawal period or milk withholding time is required when used according to the label. Avoid contact with food. Do not take internally. If accidentally ingested, drink large volumes of water. Avoid contact with skin and eyes. If accidental contact occurs, flush thoroughly with running water. Seek medical attention immediately after oral exposure or contact with skin and eyes. Avoid breathing vapours. Do not use for cleaning and/or sanitizing milking equipment. Keep out of reach of children.

ACTIVE INGREDIENTS:

Chlorhexidine acetate 0.5 % w/w

INDICATIONS:

BRAND NAME is a post-milking teat antiseptic solution to be used as an aid in reducing the spread of organisms which may cause mastitis in dairy cattle.

DIRECTIONS FOR USE: Use at full strength. Do not dilute.

Apply BRAND NAME to each teat immediately after milking. Ensure that the solution thoroughly covers the entire surface of all teats. Allow teats to dry. Do not wipe. If outside temperature is below freezing, allow to air dry on the teats before turning cows out to cold weather to prevent freezing. When a cow is being dried off, continue the application of BRAND NAME to all teats once daily for 1 to 2 weeks as required after the last milking. With freshening cows, resume application of BRAND NAME to all teats twice daily for 7 to 10 days before calving.

A fresh solution should always be used at each milking. The application equipment should be cleaned and rinsed properly after each milking session or when the solution becomes contaminated. Do not pour remaining solution back into the original container. Keep container closed to prevent contamination of the product.

CAUTIONS: For external use only. If cow’s teats are sore, irritated or chapped, consult a veterinarian before starting or continuing to use teat antiseptic.

STORAGE CONDITIONS:

Store between 4°C and 25°C. Keep from freezing.  Store in a cool, dry, clean area. Keep away from direct sunlight and heat to avoid deterioration. Keep container tightly closed.

Manufactured by:

Company ABC, 123 Street, City, Province, Postal Code

LOT : XXXXXX
EXP : XX/XX

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