Arrow Brand Medicated Oil & Embrocation

Starting date:

November 22, 2010

Posting date:

November 22, 2010

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products, Affects children, pregnant or breast feeding women

Source of recall:

Health Canada

Issue:

Poisoning Hazard, Product Safety, Unauthorized products

Audience:

General Public

Identification number:

RA-120001306

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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

Product names

Arrow Brand Medicated Oil & Embrocation- This product also comes labelled in Spanish as "Aceite Medicinal La Flecha" or in Mandarin (as shown in photos below).

Manufacturer / Place of origin

Manufactured by Kwan Dong Tung Pak Tong Medicine Manufactory Ltd. (Hong Kong) and distributed by Casa El Oriental de Fermin Fong (Dominican Republic)

Product description

Arrow Brand Medicated Oil & Embrocation is promoted for the treatment of a variety of conditions: cuts, burns, bruises, insect bites, sprains, dislocations, fainting fits, stiff muscles, headaches, colds, coughs, stomach-aches, cramps and toothaches. It also claims to prevent against influenza and contagious diseases. According to the packaging, this product is recommended for oral (taken by mouth) or topical (applied to the skin) use.

Reason for warning

The U.S. FDA informed warned consumers not to buy or use Arrow Brand Medicated Oil & Embrocation because it contains ingredients that are potentially poisonous, particularly in children.

According to the label, the ingredients include methyl salicylate, eucalyptus oil and camphor.

Methyl salicylate is poisonous if ingested and is not permitted for internal use in Canada, while camphor and eucalyptus oil may be poisonous if ingested in excess, particularly in children.

All three ingredients can be poisonous if applied to a large area of the skin or when combined with heat to increase absorption.

The labelling and packaging for this product does not provide dosing instructions or specific guidance for use, either orally or topically, which may increase the risk of toxicity.

According to the FDA warning, the product is sold primarily in U.S. specialty stores that serve Asian and Latino communities and on the Internet.

For more information on the risks of camphor and eucalyptus oil when ingested by children, Health Canada has published an It's Your Health article on the subject.

Possible side effects

Symptoms of poisoning from methyl salicylate may include: abdominal pain, nausea, vomiting, diarrhea, headache, visual changes, dizziness and mental confusion.

Reported side effects in children from swallowing health products containing camphor and/or eucalyptus oil vary from minor symptoms, such as burning sensation in the mouth, headache, nausea, and vomiting, to more severe and life threatening reactions such as seizures.

Some cases of accidental overdose of methyl salicylate and camphor have been fatal.

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

Report health or safety concerns

• 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

Images

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