melem skin and lip balm

MELEM USA LLC
PO BOX 146
WINTER PARK, CO 80482
United States
ph: 970 726 4425
fax: 970 726 8302
alt: 303 810 0809
melemusa@melemorder.com

The manufacturer's certification that Melem currently being shipped is good through January 2011 can be found on the expiration date certification page.

US FOOD AND DRUG ADMINISTRATION (FDA) EXIPRATION DATE REGULATION INFORMATION (Copied from the www.fda.gov web site)

U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors Fact Sheet
March 9, 2000; revised October 15, 2002

Shelf Life - Expiration Date

There are no regulations or requirements under current United States law that require cosmetic manufacturers to print expiration dates on the labels of cosmetic products. Manufacturers have the responsibility to determine shelf life for products, as part of their responsibility to substantiate product safety. FDA believes that failure to do so may cause a product to be adulterated or misbranded.

Voluntary shelf-life guidelines developed by the cosmetic industry vary, depending on the product and its intended use. For instance, a 1980 article by David Pope in Drug and Cosmetic Industry suggested a minimum shelf life of 18 to 24 months "to maximize cost efficiency in warehousing, distribution, and marketing."

The 1984 text Cosmetic and Drug Preservation: Principles and Practice, edited by Jon J. Kabara, recommends testing product stability by evaluating samples at regular intervals for 3 years or longer, depending upon the product.

The European Union's Cosmetic Directive, as amended in 1993, requires expiration dating only for products whose "minimum durability" is less than 30 months.

The shelf life for eye-area cosmetics is more limited than for other products. Because of repeated microbial exposure during use by the consumer and the risk of eye infections, some industry experts recommend replacing mascara 3 months after purchase. If mascara becomes dry, discard it. Do not add water or, even worse, saliva to moisten it, because that will introduce bacteria into the product. If you have an eye infection, consult a physician immediately, stop using all eye-area cosmetics, and discard those you were using when the infection occurred.

Among other cosmetics that are likely to have an unusually short shelf life are certain "all natural" products that may contain plant-derived substances conducive to microbial growth. It also is important for consumers and manufacturers to consider the increased risk of contamination in products that contain non-traditional preservatives, or no preservatives at all.

Consumers should be aware that expiration dates are simply "rules of thumb," and that a product's safety may expire long before the expiration date if the product has not been properly stored. Cosmetics that have been improperly stored - for example, exposed to high temperatures or sunlight, or opened and examined by consumers prior to final sale - may deteriorate substantially before the expiration date. On the other hand, products stored under ideal conditions may be acceptable long after the expiration date has been reached.

Sharing makeup increases the risk of contamination. "Testers" commonly found at department store cosmetic counters are even more likely to become contaminated than the same products in an individual's home. If you feel you must test a cosmetic before purchasing it, apply it with a new, unused applicator, such as a fresh cotton swab.

For more information, see: Cosmetic Safety

FDA PUBLIC HEALTH WARNINGS ABOUT CERTAIN PRESCRIPTION DRUGS USED FOR TREATING PSORIASIS AND ECZEMA

FDA Public Health Advisoiy: Elidel (pimecrolimus) Cream and Protopic (tacrolimus) Oi...

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FDA Public Health Advisory
Elide! (pimecrolimus) Cream and Protopic (tacrolimus) Ointment
The FDA is issuing a public health advisory to inform healthcare providers and patients about a potential cancer risk from use of Elide! (pimecrolimus) and Protopic (tacrolimus), products that are applied to the skin. This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work. It may take human studies often years or longer to determine if use of Elidel or Protopic is linked to cancer. In the meantime; this risk is uncertain and FDA advises that Elidel and Protopic should be used only as labeled, for patients who have failed treatment with other therapies.
The FDA recommends that healthcare providers, patients and caregivers consider the following:
• Use Elidel and Protopic only as second-line agents for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.
• Avoid use of Elidel and Protopic in children younger than 2 years of age. The effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical studies, infants and children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than did those treated with placebo cream.
• Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of Elide! and Protopic are unknown.
• Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.
• Use the minimum amount of Elidel or Protopic needed to control the patient’s symptoms. In animals, increasing the dose resulted in higher rates of cancer.
Elidel cream and Protopic ointment are topical immunosuppressant calcineurin inhibitors that are applied to the skin and are the only approved drug products in this class.
Animal studies have shown that three different species of animals developed cancer following exposure to these drugs applied topically or given by mouth, including mice, rats and a recent study of monkeys. These studies were conducted at doses higher than generally used by patients

FOR DRUG EVALUaTION AND REsEARCH

http://www.fda.gov/cder/drug/advisory/elidel_protopic.htm

4/17/2005

FDA Public Health Advisory: Elidel (pimecrolimus) Cream and I’rotopic (tacroilmus) vi... rage ut ,
and the risk of cancer increased with increasing drug dose and duration.
In addition to an ointment, tacrolimus, also comes as a pill or by injection, this form is known as (Prograf). Prograf is approved to prevent liver or kidney transplant rejection. It is known to cause both skin cancers and lymphoma in humans by suppressing the body’s normal immune defenses against cancer. The cancer risk increases with higher doses and longer treatment courses of Prograf Both Elidel and Protopic are sometimes absorbed through the skin, though usually at very low amounts. Occasionally, children who have been treated with Elidel or Protopic have had high blood levels of these drugs.
Protopic was approved in December 2000 and Elidel in December 2001. Since their approval, FDA has received reports of lymphoma and skin cancer in children and adults treated with Elidel or Protopic; whether the reported cancers are associated with these products has not been clearly established.
Based on the advice of the FDA Pediatric Advisory Committee, which met on February 15, 2005, to review these findings, FDA will require labeling changes for Elidel and Protopic, including the placement of a boxed warning about the potential cancer risk. In addition, FDA will work with the commercial sponsors of the drugs to develop and implement a Medication Guide (MedGuide) to provide this information and instructions about appropriate use of Elidel and Protopic to patients, their families, and caregivers. MedGuides are intended to be distributed by pharmacists with each prescription or refill of a medication.
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http://www.fda.gov/cder/drug/advisory/elidel_protopic.htm 4/17/2005