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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:
At any concentration where Dimethicone is associated with a health claim (e.g. as a barrier in diaper rash products), Dimethicone is classified as a drug medicinal ingredient subject to the Food and Drug Regulations, not an NHP.
Reference:  NHPD