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Drugs and Health Products

Chemical Substance - Dimethicone

NHPID Name:
Dimethicone

Reference:

Proper Name(s):

Common Name(s):

Category:
Approved Chemical Name

CAS Registry Number:





Roles

Non-medicinal

Purposes:

Restrictions:

Acceptable Daily Intake

Upper Limit:
0.8

Units:

Detail:
Temporary acceptable daily intake (ADI) of 0-0.8 mg/kg bodyweight, based on the previous ADI of 0-1.5 mg/kg bodyweight and applying an additional safety factor of 2.

Reference:


General

Detail:
When it is not associated with a health claim and has a valid non-medicinal purpose, Dimethicone is an acceptable non medicinal ingredient in a drug product or a natural health product in the minimum concentration necessary to achieve the excipient effect.

Reference:


Non-NHP

Rationale:
Dimethicone is a non-NHP because it is not falling under Schedule 1 to the NHP Regulations. If dimethicone is declared as a medicinal ingredient in a product, the product is a drug, not an NHP. A Drug Identification Number Application should be submitted to Health Canada for this product.If dimethicone is 1) declared as a non-medicinal ingredient and 2) is present at a concentration that is less than 1%, the product is an NHP. A Natural Health Product Licence Application should be submitted to Health Canada for this product.If dimethicone is 1) declared as a non-medicinal ingredient and 2) is present at a concentration that is greater than or equal to 1% and 3) it contributes to the claim (e.g. the Recommended Use or Purpose on the product is a statement to the effect of those permitted for dimethicone on the Diaper Rash Products or Medicated Skin Care Products monographs), then the product is considered a drug. A Drug Identification Number Application should be submitted to Health Canada for this product.If dimethicone is 1) declared as a non-medicinal ingredient and 2) is present at a concentration that is greater than or equal to 1% and 3) does not contribute to the claim (as defined above), the product is an NHP. A Natural Health Product Licence Application should be submitted to Health Canada for this product.
Reference:  NHPD