Chemical Substance - White petrolatum

NHPID name:
White petrolatum

Reference:
USP_31

Proper name(s):
White petrolatum

Common name(s):

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




Roles

Non-medicinal

Purposes:
Lubricant , Ointment Base
Restrictions:

General:

Route Of administration:
Topical

Detail:
When it is not associated with a health claim and has a valid non-medicinal purpose, White 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 White petrolatum present in a natural health product be of food / pharmaceutical grade (e.g. FCC / USP). For topical use only.

Reference:
KIBBE

Non-NHP

Rationale:

White petrolatum is a non-NHP because it is not falling under Schedule 1 to the NHP Regulations. If white 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 white 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 white 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 white 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 white 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
Report a problem on this page
Date modified: