Regrowth's 2% Ketoconazole/3% Salicylic Acid Treatment Shampoo with package insert

As of Thursday, 21 March, 2002, Regrowth Treatment Shampoo is available to Dr. Lee's patients.

Regrowth Treatment Shampoo contains 2% ketoconazole and 3% salicylic acid, so it has the combined benefits of Nizoral 2% shampoo and Neutrogena T-sal. It helps prevent the synthesis of DHT in the scalp and will likewise help to control dandruff. Like all other products featured at www.minoxidil.com, it is a prescription item.

We suggest that Nizoral's Daily Conditioner be used after shampooing with the Regrowth Treatment Shampoo. If Nizoral's Daily Conditioner is used in conjunction with Regrowth's Treatment Shampoo, most patients will not notice the 'itchy feeling' generally associated with Nizoral's 2% Ketoconazole shampoo. Please keep in mind that it is not necessary to shampoo one's hair daily, and that the new Regrowth Treatment Shampoo is designed to be used two - three times a week. If you are accustomed to shampooing on a daily basis, use some other shampoo on the days you do not use the new Regrowth Treatment Shampoo.

The price of the new Regrowth Treatment Shampoo is $13.90 per bottle, and is available in a four ounce container. It is reported that Nizoral's 2% ketoconazole shampoo also comes in a four ounce container.

Regrowth's new, prescription 2% ketoconazole shampoo should not be confused with any non-prescription shampoos previously sold by Regrowth .

If you wish to place an order for the new Regrowth Treatment Shampoo, and are already one of Dr. Lee's U.S.A. patients, or live abroad, you can click on the following link to go to the index where you can enter the Secure Order Form. Look for Product #420.

Index

If you are not yet one of Dr. Lee's U.S. patients and wish to become one, please click on the following link and place the word Consultation in the Subject line: Regrowth@minoxidil.com/

Regards,

Richard Lee, M.D.

Package Insert for Regrowth Treatment Shampoo

The Regrowth Treatment Shampoo is formulated with 2% ketoconazole and 3% salicylic acid to benefit in the treatment of alopecia androgenetica and to combat dandruff . Ketoconazole has been proven to decrease the quantities of DHT in the scalp by helping to inhibit its synthesis from sterols. Salicylic acid has a keratolytic and a slight antiseptic action when applied topically to the skin. By removing some of the dead epidermal layers of the stratum corneum, there is an enhanced action by the ketoconazole in suppressing the production of DHT in the scalp.

The ingredients of the Regrowth Treatment Shampoo include: Ketoconazole 2%, Salicylic Acid 3%, purified water, hydrolyzed keratin protein, quarternium 19, sodium styrene/acrylates/divinylbenzene polymer, sodium laureth cocamidopropyl betaine, sodium laureth sulfate, panthenol, soapbark, citric acid, allantoin, methylparaben, glyceryl PABA, sodium chloride, fragrance, red coloring, imidurea, sodium hydroxide

Directions for Use:

1. Moisten hair and scalp thoroughly with water.

2. Apply sufficient Treatment Shampoo to produce enough lather to wash the scalp and hair; gently massage it over the entire scalp for approximately 1 minute.

3. Rinse the hair thoroughly with warm water.

4. Repeat, leaving the Treatment Shampoo on the scalp for an additional 5 minutes.

5. Rinse again thoroughly with warm water.

6. Apply a daily conditioner, such as Nizoral Daily Conditioner.

7. Dry the hair with a towel or a warm blow dryer.

Shampoo two or three times / week with the Regrowth Treatment Shampoo. You may choose to use other shampoos and conditioners of your choice on the alternative days.

Warnings: Adverse effects reported in patients receiving topical 2% ketoconazole as a shampoo to the scalp include skin irritation, abnormal hair texture, scalp pustules, dry skin, pruritis (itching), and oiliness or dryness of the hair or scalp. There have been reports that use of 2% ketoconazole shampoo resulted in removal of the curl from permanently waved hair. Although there have been rare reports of increased hair loss, it has not been determined to be directly due to the use of topical 2% ketoconazole.

Care should be taken to avoid getting Treatment Shampoo in the eyes or on the mucous membranes of the mouth. In case it does occur, rinse the eyes or mouth with copious amounts of water. Salicylic acid has the potential of causing an altered appearance of the hair after extended use.

Storage: The Regrowth Treatment Shampoo (2% ketoconazole / 3% salicylic acid) should be stored at temperatures not exceeding 77^oF (25^oC) and should be protected from direct sunlight.

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