Analgesics Labelling standard

Anorectal Drugs - Labelling Standards - Non-prescription Drugs

June 5, 2014 – 05:34 pm

NATIONAL ELECTRICAL CODE 2011

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Labelling Standard

1. Definition:

A topical or intrarectal nonprescription drug that is used to relieve symptoms caused by anorectal disorders in the anal canal, perianal area, and/or the lower rectal areas.

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.

2. Medicinal Ingredients and Concentrations:

All finished product and ingredients used in the manufacture of the product should comply with the specifications of Schedule B pharmacopoeial or equivalent standard.

The medicinal ingredients of a product complying with this standard consist of the following ingredients when used singly or in acceptable combinations within the established limits given:

  1. benzocaine 5 - 20%
  2. benzyl alcohol 1 - 4%
  3. dibucaine (hydrochloride) 0.25 - 1%
  4. dyclonine hydrochloride 0.5 - 1%
  5. lidocaine 2 - 5%
  6. pramoxine hydrochloride 1%
  7. tetracaine (hydrochloride) 0.5 - 1%
  1. ephedrine sulfate 0.1 - 1.25%
  2. epinephrine (hydrochloride) 0.005 - .01%
  3. phenylephrine hydrochloride 0.25%
  • the following may be used as a single ingredient in a product if it comprises 50% or more by weight of the final product
  • the following may be used in combinations in accordance with 3.1
    1. aluminum hydroxide gel
    2. cocoa butter
    3. glycerin in a 20 - 45% (w/w) aqueous solution
    4. kaolin
    5. lanolin
    6. mineral oil
    7. petrolatum
    8. topical starch
    9. white petrolatum
  • the following may not be used as a sole protectant ingredient but may be used in combination with other protectant ingredients in accordance with 3.1
    1. calamine (not to exceed 25% by weight per dosage unit - based on the zinc oxide content of calamine
    2. cod liver oil
    3. shark liver oil
    4. zinc oxide (not to exceed 25% by weight per dosage unit)
  1. camphor 0.1 - 3%
  2. uniper tar 1 - 5%
  3. menthol 0.1 - 1%
  1. calamine, within a concentration of 5-25% by weight per dosage unit (based on the zinc oxide content of calamine)
  2. hamamelis water, NFXI, 10-50%
  3. zinc oxide 5-25% by weight per dosage unit
  1. alcloxa 0.2 - 2%
  2. resorcinol 1 - 3%

3. Permitted Combinations

Any two, three of four protectants identified in 2.3 may be combined provided the combined percentage (by weight) is at least 50% of the final product (eg. 1g of a 2g dosage unit). Any protectant included in the combination must be present at a level that contributes at least 12.5% by weight (eg. 0.25g of a 2g dosage unit), except cod liver oil and shark liver oil.

Any single anorectal ingredient identified in 2.1, 2.2., 2.4, 2.5 and 2.6 may be combined with up to four protectants in accordance with 3.1

Any single local anesthetic (2.1) with any single vasoconstrictor (2.2)

Any single local anesthetic (2.1) with any single astringent (2.5)

Any single local anesthetic (2.1) with any single keratolytic (2.6)

Any vasoconstrictor (2.2) with any single astringent (2.5)

Any single analgesic, anesthetic, antipruritic (2.4) with any single astringent (2.5)

Source: www.hc-sc.gc.ca


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