Topical Anaesthetic / Analgesic / Antipruritic

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Labelling Standard

Category:

Topical analgesic, anaesthetic and antipruritic preparations for the temporary relief of pain and itching due to minor burns, sunburn, minor cuts, abrasions, insect bites and minor skin irritations

Definition

Topical Analgesic/Anaesthetic/Antipruritic: a drug applied to the skin that relieves pain and/or itching by depressing cutaneous sensory receptors.

Pharmaceutical Forms: cream, ointment, solution, lotion, aerosol, gel

Note: In the case of applications for drugs which fit the criteria of this labelling standard, it is not necessary to conduct an assessment to determine if bioequivalence, pharmacodynamic/clinical studies or pharmaceutical equivalence data must be submitted.

Medicinal Ingredients:

The finished product and all ingredients used in the manufacture of the product comply with specifications of Schedule B pharmacopoeia (standards) or an equivalent standard.

The medicinal ingredients of a product complying with this standard consist of the following when used singly, within the established limits, or in an acceptable combination

Single Ingredient Products	Concentration:(/g)
(A) Amine and "Caine"-type
Benzocaine	5 to 20 %
Butamben picrate	1 %
Dibucaine (or Dibucaine HCl)	0.25 to 1 %
Dimethisoquin HCl	0.3 to 0.5 %
Dyclonine HCl	0.5 to 1 %
Lidocaine (or Lidocaine HCl)	0.5 to 5 %
Pramoxine HCl	0.5 to 1 %
Tetracaine (or Tetracaine HCl)	1 to 2 %
(B) Alcohols and Ketones
Benzyl alcohol	10 to 33 %
Camphor	0.1 to 3 %
Camphorated Metacresol:
with Camphor )	( 3 to 10.8 %
and Metacresol )	( 1 to 3.6 %
Juniper tar	1 to 5 %
Menthol	0.1 to 1 %
Phenol	0.5 to 1.5 %
Phenolate sodium	0.5 to 1.5 %
Resorcinol	0.5 to 3 %
(C) Antihistamines
Diphenhydramine HCl	1 to 2 %
Tripelennamine HCl	0.5 to 2 %

Permitted Combinations:

Combinations of external analgesic active ingredients:

1. Any ingredient in (A) with any ingredient in (B).
2. Any ingredient in (B) with any ingredient in (C).
3. Any one of:
   • Benzyl alcohol )(as in B)
   • Juniper tar )
   • with camphor and Phenol )
   • menthol (as in B)
   • Phenolate sodium)
   • Resorcinol )
4. Camphor 3 to 10.8 % )
5. Phenol 4.7 % )

Combinations of external analgesic active ingredients and other active ingredients:

1. Any ingredient in (A, B, C) or any permitted combination may be combined with a skin protectant ingredient (as listed in Table I) or combination of skin protectant ingredients. Note: The declaration of the skin protectant ingredient as a medicinal ingredient is optional. However, if it is declared as medicinal, then the concentration must meet the minimum level indicated in Table I.

Table I: Minimum Skin Protectant Ingredient and Concentrations

Skin Protectant Ingredient	Minimum Concentrations (%)
Allantoin	0.5
Aluminum hydroxide gel	0.15
Calamine	1
Cocoa butter	50
Dimethicone	1
Glycerin	20
Kaolin	4
Petrolatum	30
Shark liver oil	3
White petrolatum	30
Zinc acetate	0.1
Zinc carbonate	0.2
Zinc oxide	1

Adequate Directions for Use:

Indications: The inner and outer labels shall bear a statement of the indications for use, to the effect:

For Topical Anaesthetic/Analgesic/Antipruritic Ingredients:

• For temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations

For Combination with Skin Protectant Ingredients a statement may be added, to the effect: **

• ... and for the temporary protection of minor skin irritations

** Note: If such a claim is made, then the skin protectant ingredient(s) must be declared as a medicinal ingredient on the label and meet the minimum concentration level indicated in Table I.

Dosage Directions: The inner and outer labels shall carry a statement that indicates that:

• Adults and children 2 years of age and older: Apply (Spray) to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Warnings: The inner and outer labels shall carry the following statements:

For All Topical Anaesthetic/Analgesic Ingredients:

• for external use only
• avoid contact with eyes; if this happens, rinse thoroughly with water
• if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor

For Butamben picrate:

• do not apply over large areas of the body
• this product stains skin and clothing yellow

For Dibucaine, Dibucaine HCl, Lidocaine, Lidocaine HCl, Tetracaine, Tetracaine HCl:

• do not use in large quantities, particularly over raw surfaces or blistered areas

For Camphorated metacresol, Phenol, Phenolate sodium:

• do not apply over large areas of the body or under a bandage

For Resorcinol:

• do not apply over large areas of the body

Note:

* See also Counterirritant Labelling Standard

Note: This labelling standard describes those requirements that are specific to this class of drugs. Other requirements described in the Regulations to the Food and Drugs Act and in the Guide for the Labelling of Drugs for Human Use should also be met

Bureau of Nonprescription Drugs
revised: September 1, 1994

References

1. United States Federal Register Vol. 48, No. 27 February, 1983 pp 5852-5869 External Analgesic Drug Products for Over-the-Counter Human Use; Tentative Final Monograph
2. United States Federal Register Vol. 44, No. 234 December, 1979 pp 69768-69866 External Analgesic Drug Products for Over-the-Counter Human Use; Establishment of a Monograph and Notice of Proposed Rule Making
3. AMA Drug Evaluations Annual, 1992, American Medical Association
4. Remington's Pharmaceutical Science, 18th Edition, 1990, Philadelphia College of Pharmaceutical Sciences
5. Self-Medication. A Reference for Health Professionals, 4th Edition, 1992, Canadian Pharmaceutical Association
6. American Handbook of Nonprescription Drugs, 9th Edition, 1990, American Pharmaceutical Association
7. Canadian Drug Identification Code Book, 18th Edition, 1992, Health and Welfare Canada
8. Martindale, The Extra Pharmacopoeia, 29th Edition, 1989, The Pharmaceutical Press, London
9. Canadian Drug Identification Code Book, 8th Edition, 1981, Health and Welfare Canada
10. Food and Drug Act and Regulations, Schedule F
11. Information Letter No. 714, September 10, 1986. Subject: Availability of Nonprescription Topical Preparations Containing Hydrocortisone
12. Drug Information for the Health Care Professional, 12th Edition, 1992, The United States Pharmacopoeial Convention, Inc., Rockville, MD
13. Drug Facts and Comparisons, 1989. J. B. Lippincott Company, Facts and Comparisons Division, St. Louis, Missouri
14. United States Federal Register Vol. 52, No. 238 December 11, 1987 pp. 47312-47324. Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Final Monograph for OTC First Aid Antibiotic Drug Products; Final Rule