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




Toxicity restriction:

Upper limit:
17.0

Units:
Milligrams/kilogram body weight/day

Detail:
Acceptable daily intake up to 17 mg/kg bw/day.

Related links:

Reference:
EFSA_E900_FOOD_18


Roles

Non-medicinal

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

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


General:

Route Of administration:
Topical

Allowed purposes:
Antifoaming Agent , Skin-Conditioning Agent - Occlusive , Skin Protectant

Reference:
ICID


General:

Route Of administration:
Oral

Allowed purposes:
Antifoaming Agent

Reference:
WHO_JECFA


General:

Route Of administration:
Topical

Allowed purposes:
Emollient

Reference:
USP-NF Online

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
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