HAIR REGROWTH TREATMENT
Actavis Mid Atlantic LLC
If swallowed, get medical help or contact a Poison Control Center right away.
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This Package Contains:
Using the Dropper Applicator:
Minoxidil Topical Solution is for men who have a general thinning of hair on the top of the scalp (vertex) as shown. Minoxidil Topical Solution has been shown to regrow hair in men with the following degrees of thinning hair or hair loss.
If men have more hair loss than shown above, Minoxidil Topical Solution may not work.
*This product is not affiliated with, manufactured by, or produced by the makers of Rogaine®.
2004847 00660109I1 VC108596
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA
Made in Canada
Compare to the active ingredient in Men’s Rogaine®*
Regular Strength FOR MEN
HAIR REGROWTH TREATMENT
Minoxidil Topical Solution USP 2%
Clinically Proven to Help Regrow Hair
Revitalizes Hair Follicles
ONE MONTH SUPPLY 1-60 mL (2 fl oz) Bottle
ONE MONTH SUPPLY CARTON LABEL
MINOXIDIL TOPICAL SOLUTION USP 2%
Important information about – Minoxidil Topical Solution USP 2% for Men
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Minoxidil Topical Solution contains the only ingredient available without a prescription that is medically proven effective to help regrow hair.
Please read this leaflet carefully. It will help you understand how to use Minoxidil Topical Solution and what to expect from its use. If you have any questions after reading this leaflet, or anytime while using Minoxidil Topical Solution, you should ask your health care professional.
What is Minoxidil Topical Solution?
Minoxidil Topical Solution is a clear to pale yellow liquid medication for use only on the scalp to help regrow hair.
Who may use Minoxidil Topical Solution?
Minoxidil Topical Solution may be appropriate for you if you are an adult who is at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of the head. The common hereditary thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss.
Minoxidil Topical Solution is for men with hair loss or thinning that begins at the top of the scalp (vertex) as shown below. Frontal hair growth has not been demonstrated in clinical trials. Minoxidil Topical Solution is more likely to regrow hair in men with hair loss in the range shown below. If men have more hair loss than shown, Minoxidil Topical Solution may not work.
Many of those experiencing hair loss have other family members with gradual thinning hair or hair loss. If there is no family history of gradual thinning or gradual hair loss, or hair loss is patchy, talk to your doctor.
Who should NOT use Minoxidil Topical Solution?
Minoxidil Topical Solution will not prevent or improve hair loss which may occur with the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; excessive vitamin A intake), low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp. Also, Minoxidil Topical Solution will not improve hair loss due to:
You should ask your doctor if you are unsure of the cause for your hair loss.
Will Minoxidil Topical Solution work for me?
The amount of hair regrowth is different for each person. Not everyone will respond to Minoxidil Topical Solution. The response to Minoxidil Topical Solution cannot be predicted. No one will be able to grow back all their hair.
You may respond better if you have been losing your hair for a short period of time or have little initial hair loss.
In clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, the following response of Minoxidil Topical Solution was reported:
Can Minoxidil Topical Solution be used to prevent hair loss?
We do not know if Minoxidil Topical Solution will prevent hair loss.
How soon can I expect results from using Minoxidil Topical Solution?
Since normal hair usually grows only ½ to 1 inch per month, hair regrowth with Minoxidil Topical Solution also takes time. Generally new hair growth is slow for a Minoxidil Topical Solution user. Continued use 2 times a day for at least 4 months is usually needed before you notice hair regrowth.
If you do not see hair regrowth in 4 months, stop using Minoxidil Topical Solution and see your doctor.
When you first begin to use Minoxidil Topical Solution, your hair loss may continue for up to 2 weeks. This hair loss is temporary. If you continue to lose hair after two weeks, see your doctor.
If Minoxidil Topical Solution is working, what will the hair look like?
At first, hair growth may be soft, downy, colorless hairs. After further use, the new hair should be the same color and thickness as the other hairs on your scalp.
How long do I need to use Minoxidil Topical Solution?
If you respond to Minoxidil Topical Solution, you will need to use it 2 times a day to keep and continue the hair regrowth. Up to 12 months of use may be needed to see your best results from Minoxidil Topical Solution.
What happens if I completely stop using Minoxidil Topical Solution? Will I keep the new hair?
Continuous use of Minoxidil Topical Solution is needed to maintain hair regrowth. If you stop using Minoxidil Topical Solution, the normal hair loss process will start again. You will probably lose your newly regrown hair in three to four months.
What is the dosage of Minoxidil Topical Solution?
You should apply a dose (1 mL) of Minoxidil Topical Solution directly onto the scalp in the hair loss area TWO TIMES A DAY; for example, once in the morning and once at night. Each bottle should last about one month, if used as directed. Please refer to the “Directions for Use” section of this leaflet.
What if I miss a dose or forget to use Minoxidil Topical Solution?
If you miss one or two daily doses of Minoxidil Topical Solution, just continue with your next dose. You should not make up for missed doses.
Can I use Minoxidil Topical Solution more than two times a day?
Will it work faster, better?
No. Minoxidil Topical Solution will not work faster or better if used more than 2 times a day. Studies have been carefully conducted to determine the correct amount of Minoxidil Topical Solution needed to get the best results. More frequent use or larger doses have not been shown to speed up hair growth and may increase your chance of side effects.
What are the most common side effects with Minoxidil Topical Solution?
The most common side effects are itching and other skin irritations of the treated area of the scalp. Minoxidil Topical Solution contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If Minoxidil Topical Solution accidentally gets into these areas, rinse with large amounts of cool tap water. Contact your doctor if irritation persists.
What kind of shampoo should I use with Minoxidil Topical Solution?
If you wash your scalp before applying Minoxidil Topical Solution, use a mild shampoo.
Can I use hair sprays, mousses, conditioners, gels, etc.?
Yes. There is no need to change your usual hair care routine when using Minoxidil Topical Solution. However, you should apply Minoxidil Topical Solution first and wait for it to dry before applying your styling aids.
Can I have my hair colored or permed or use hair relaxers while using Minoxidil Topical Solution?
Yes. We have no information that these treatments change the effect of Minoxidil Topical Solution. However, to avoid possible scalp irritation, you should make sure all of the Minoxidil Topical Solution has been washed out of the hair and scalp before using these chemicals.
Can I apply Minoxidil Topical Solution and wash my hair an hour later?
No. For Minoxidil Topical Solution to work best, you should allow Minoxidil Topical Solution to remain on the scalp for about 4 hours before washing.
Can I go swimming or out in the rain?
Yes. Avoid washing off the Minoxidil Topical Solution. If possible, apply Minoxidil Topical Solution to a dry scalp after swimming, or wait about 4 hours after application before going swimming. Do not let your scalp get wet from the rain after applying Minoxidil Topical Solution.
Can Minoxidil Topical Solution produce unwanted hair?
Although unwanted hair growth has been reported on the face and on other parts of the body, such reports have been infrequent. The unwanted hair growth may be caused by the transfer of Minoxidil Topical Solution to areas other than the scalp, or by absorption into the circulatory system of low levels of the active ingredient, or by a medical condition not related to the use of Minoxidil Topical Solution.
If you experience unwanted hair, discontinue using Minoxidil Topical Solution and see your doctor for recommendations about appropriate treatment. After stopping use of Minoxidil Topical Solution, the unwanted hair, if caused by the use of Minoxidil Topical Solution, should go away over time.
You can take steps to decrease the chances of unwanted hair growth: 1) limit the application of Minoxidil Topical Solution only to the scalp; 2) if you use your hands to apply Minoxidil Topical Solution, wash your hands thoroughly afterwards; and 3) allow sufficient drying time (usually 2 to 4 hours before going to bed) after your nighttime application of Minoxidil Topical Solution.
Can I use Minoxidil Topical Solution for baldness or hair loss in babies and children?
No. Minoxidil Topical Solution must not be used to treat baldness or hair loss in babies or children.
Are there any special warnings about the use of Minoxidil Topical Solution?
For external use only
Flammable: Keep away from fire or flame
Do not use if
Ask a doctor before use if you have heart disease.
When using this product
Stop use and ask a doctor if
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
What factors may increase the risk of serious side effects with Minoxidil Topical Solution?
Minoxidil Topical Solution should be applied only to the scalp. The risk of side effects may be greater when it is applied to other parts of the body.
Directions for Use
Using the Dropper Applicator
If you have any other questions, ask your health care professional.
Store at Controlled Room Temperature 20º to 25ºC (68º to 77ºF). Keep tightly closed.
Save this leaflet for future reference.
Manufactured by: Contract Pharmaceuticals Ltd.
7600 Danbro Crescent
Canada, L5N 6L6
For: Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA
FORM NO. 0066 Rev. 1/08
|HAIR REGROWTH TREATMENT
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|Labeler - Actavis Mid Atlantic LLC (809515898)|
Revised: 10/2011 Actavis Mid Atlantic LLC