Chemical Substance - Petrolatum

NHPID name:
Petrolatum

Reference:
MI

Proper name(s):
Petrolatum

Common name(s):

Category:
Approved Chemical Name
Monograph(s):
Diaper rash treatment monograph , Medicated Skin Care Products Monograph

CAS registry number:
8009-03-8




Roles

Non-medicinal

Purposes:
Antifoaming Agent , Coating Agent , Controlled Release Vehicle , Lubricant , Ointment Base , Protectant , Skin-Conditioning Agent - Occlusive
Restrictions:

General:

Detail:
When it is not associated with a health claim and has a valid non-medicinal purpose, Petrolatum is an acceptable non-medicinal ingredient in a natural health product in the minimum concentration necessary to achieve the excipient effect. It is also expected that Petrolatum present in a natural health product be of food / pharmaceutical grade (e.g. FCC / USP).

Reference:
NNHPD

Non-NHP

Rationale:

Petrolatum is a non-NHP because it is not falling under Schedule 1 to the NHP Regulations. If petrolatum 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 petrolatum is 1) declared as a non-medicinal ingredient and 2) is present at a concentration that is less than 30%, the product is an NHP. A Natural Health Product Licence Application should be submitted to Health Canada for this product.If petrolatum is 1) declared as a non-medicinal ingredient and 2) is present at a concentration that is greater than or equal to 30% 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 petrolatum 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 petrolatum is 1) declared as a non-medicinal ingredient and 2) is present at a concentration that is greater than or equal to 30% 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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