Unauthorized health product "PureCare Herbal Cream" may pose serious health risks

Starting date:
March 27, 2017
Type of communication:
Advisory
Subcategory:
Natural health products, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Issue:
Poisoning Hazard
Audience:
General Public
Identification number:
RA-62810

Issue

Health Canada is advising Canadians that the unauthorized health product “PureCare Herbal Cream” may pose serious health risks. The product is promoted as a natural treatment for eczema and psoriasis in children and babies. Health Canada testing confirmed the presence of a prescription steroid (clobetasol propionate) and another ingredient (phenoxyethanol) not declared on the product label. These ingredients may cause health effects ranging from skin irritation and dehydration to increased blood pressure.

PureCare Herbal Cream was sold online at www.purecareskin.com and through an in-person distribution network. The product has been sold with two different labels (images below). The current label states the product is “FOR EXTREMELY DRY SKIN” and the previous label states it is an “Herbal Cream for Eczema, Psoriasis & Dry Skin.” The product was imported by the company PureCare Herbal Cream Ltd.

Products affected

  • “PureCare Herbal Cream,” by PureCare Herbal Cream Ltd.

What you should do

  • Stop using this product. Consult with your health care professional if you have used this product and have health concerns.
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.
  • Report adverse events to health products to Health Canada by calling toll-free at 1 866 234 2345, or by reporting online, by mail or by fax.
  • Report complaints about health products to Health Canada by calling toll-free at 1 800 267 9675, or complete an online complaint form.

Who is affected

  • Consumers who have bought or used this product.

Background

Clobetasol propionate is a super-high potency topical steroidal prescription drug used to treat inflammatory conditions. It should be used only under the supervision of a health care professional. Side effects include skin irritation, weakening or degeneration. Topical corticosteroids can be absorbed in sufficient amounts to produce adverse effects, including irregular heartbeat, increased blood pressure, stomach ulcer, increased blood sugar, blood disorders, skin, muscle and bone damage, and nervous system disorders.

Phenoxyethanol can pose serious health risks if ingested – for example, by infants during nursing if the mother has applied the product to help soothe and heal dry or cracked nipples. If ingested, phenoxyethanol can cause difficulty breathing, vomiting and diarrhea. Vomiting and diarrhea can lead to dehydration.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada confirmed that the company, PureCare Herbal Cream Ltd., has stopped selling the product. Health Canada has requested that the company recall it from the market.

Images

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For more information

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools. To learn more about natural health products and other self-care products, visit Canada.ca/selfcare-products.