Archived – Mommy's Bliss Nipple Cream

Starting date:

June 30, 2008

Posting date:

June 30, 2008

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products

Audience:

General Public

Identification number:

RA-12000403

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

U.S. Food and Drug Administration (FDA)

Product name

Mommy's Bliss Nipple Cream

Manufacturer / Place of origin

MOM Enterprises Inc., San Rafael, California

Product description

Mommy's Bliss Nipple Cream is promoted as an all-natural product to help soothe and heal dry or cracked nipples.

Reason for warning

The FDA warned consumers not to use the product because it contains the preservatives chlorphenesin and phenoxyethanol. In Canada, these two substances are not considered to be naturally occurring and would not be permitted in a natural health product.

Possible side effects

• Nursing infants could potentially experience serious side effects, including difficulty breathing and dehydration, if they ingest this product.
• Chlorphenesin relaxes skeletal muscle. It can slow down the brain function and cause slow or shallow breathing in infants.
• Phenoxyethanol can also slow down the brain function. It may cause vomiting and diarrhea, which can lead to dehydration in infants.
• Chlorphenesin can also harm the mother by causing irritation of the nipple and surrounding skin.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709

Images

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