- Approval Id
- f4b9141df29d1747
- Drug Name
- REGAINE EXTRA STRENGTH (5%)
- Product Name
- REGAINE EXTRA STRENGTH (5%)
- Approval Number
- SIN08213P
- Approval Date
- 1995-06-19
- Registrant
- JOHNSON & JOHNSON PTE. LTD.
- Licence Holder
- JOHNSON & JOHNSON PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- GENERAL SALE LIST
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>How and when to use REGAINE®</strong></p>
<ul>
<li>REGAINE® must only be applied when the hair and scalp are completely dry.</li>
<li>You should continue to use REGAINE® as directed by your pharmacist or doctor. Once REGAINE® is stopped, the appearance of your hair will return to how it was before you started to use REGAINE®.</li>
</ul>
<p><strong>Directions For Use:</strong></p>
<p>For topical use only. The hair and scalp should be thoroughly dry prior to topical application.</p>
<p>Apply one dose (1 mL) of REGAINE® to the hair loss area of your scalp two times a day, preferably morning and night.</p>
<p>Massage the solution lightly into your scalp, and wash your hands well afterwards. Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp. This dose should be used no matter what the size of the bald spot is. More frequent use or larger doses have not been shown to speed up hair growth and may increase your chances of side effects.</p>
<p>It has been shown that twice daily use of REGAINE® may be required for at least four months before you will see the evidence of cosmetically acceptable hair growth.</p>
<p>Response to treatment with REGAINE® may vary widely, and some patients may see faster results than others. Make sure the scalp is dry and that the skin is healthy and intact.</p>
<p>The method of application varies according to the disposable applicator used, as indicated below.</p>
<ol type="A">
<li><strong>PUMP SPRAY APPLICATOR</strong>
<ol>
<li>This applicator works best for applying REGAINE® to large areas of the scalp.</li>
<li>Remove large outer cap; remove small inner cap and discard it.</li>
<li>Insert the pump spray applicator into bottle and screw on firmly.</li>
<li>After aiming the pump toward the center of the bald area of the scalp, press the pump once and spread REGAINE® with fingertips to cover all of the bald area.</li>
</ol>
<p>Repeat for a total of 6 times, to apply a dose of 1 ml of solution. Avoid breathing spray mist. Place large outer cap on bottle when not in use.</p>
</li>
<li><strong>EXTENDED SPRAY-TIP APPLICATOR</strong>
<ol>
<li>This applicator works best for applying REGAINE® to small areas of the scalp or under hair.</li>
<li>The pump spray applicator must be on the bottle to use the extended tip applicator. Follow steps A.2 and A.3.</li>
<li>Remove small spray head from top of pump spray applicator; fit the extended spray tip applicator onto the spray shaft and push down firmly. Remove the small cap on the end of the extended tip.</li>
<li>After aiming the applicator toward the center of the bald area of the scalp, press the pump once and spread REGAINE® with fingertips to cover all of the bald area. Repeat for a total of 6 times, to apply a dose of 1 ml of solution. Avoid breathing spray mist. If desired, replace the small cap on end of extended tip when not in use.</li>
</ol>
</li>
</ol>
- Route Of Administration
- TOPICAL
- Indication Info
- <p><strong>What REGAINE® is used for and how it works</strong></p>
<p>REGAINE® is used for the treatment of hair loss in man and woman. REGAINE® stimulates hair growth and stabilizes hair loss in patients experiencing hair loss or hair thinning.</p>
- Contraindications
- <p><strong>Do not use REGAINE® if:</strong></p>
<ul>
<li>You do not have a family history of hair loss.</li>
<li>Your hair loss is patchy and/or sudden, or if the reason for the hair loss is unknown.</li>
<li>The hair loss is due to childbirth.</li>
<li>Your scalp is red, inflamed, irritated, infected or painful.</li>
<li>You have had an allergic reaction to REGAINE® or any of its ingredients.</li>
<li>You are currently using any topical medications on the scalp.</li>
<li>You are under 18 or over 65 years of age.</li>
<li>The expiry date (EXP) printed on the pack has passed.</li>
<li>You are pregnant or breastfeeding.</li>
</ul>
- Atc Code
- D11AX01
- Atc Item Name
- minoxidil
- Pharma Manufacturer Name
- JOHNSON & JOHNSON PTE. LTD.
