Chemical Substance - Dimethicone

NHPID name:
Dimethicone

Reference:
MI

Proper name(s):

Common name(s):
Dimethicone

Category:
Approved Chemical Name
Monograph(s):
Diaper Rash Products , Medicated Skin Care Products

CAS registry number:
9006-65-9

Other registry numbers:
141-62-8 , 63148-62-9




Roles

Non-medicinal

Purposes:
Antifoaming Agent , Emollient , Skin-Conditioning Agent - Occlusive , Skin Protectant
Restrictions:

Acceptable Daily Intake

Upper limit:
0.8

Units:
Milligrams/kilogram body weight/day

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:
JECUP08


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:
NNHPD


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:  NNHPD