[The following information is based on the container labeling in effect on June 25, 1996.]
MINOXIDIL
TOPICAL SOLUTION 2%
Hair Regrowth Treatment for Men
Medically proven to help regrow hair
Same as former prescription strength
60 mL (2 fl oz)
Do not use if you are under 18 years of age. For external use only
NDC 0472-0066-73
CONTENTS: One 60 mL (2 fl oz) bottle of Minoxidil Topical Solution (lasts about 25-30 days) Dropper (not child resistant) Information leaflet for men
NDC 0472-0066-75
CONTENTS: Two 60 mL (2 fl oz) bottles of Minoxidil Topical Solution (each lasts about 25-30 days) Dropper (not child resistant) Information leaflet for men
NDC 0472-0066-77
CONTENTS: Three 60 mL (2 fl oz) bottles of Minoxidil Topical Solution (each lasts about 25-30 days) Dropper (not child resistant) Information leaflet for men
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 hairloss.
If men have more hairloss than shown above, Minoxidil Topical Solution may not work.
ACTIVE
INGREDIENT: Minoxidil 2% w/v
PURPOSE: Hair regrowth treatment.
USE: To regrow hair on the scalp.
It takes time to regrow hair. You may need to use Minoxidil Topical Solution daily for at least 4 months before you see results.
The amount of hair regrowth is different for each person. Minoxidil Topical Solution will not work for everyone.
In clinical studies of mostly white men aged 18-49 years with moderate degrees of hairloss, the following response to Minoxidil Topical Solution was reported:
26% of men reported moderate to dense hair regrowth after using Minoxidil Topical Solution for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth).
If your degree of hairloss is more than that shown on the illustrations, Minoxidil Topical Solution may not work.
Continued use is necessary to increase and keep your hair regrowth or hairloss will begin again. If you do not see hair regrowth in 12 months, stop using and see your doctor.
DIRECTIONS: FOR EXTERNAL USE ONLY. Apply one mL 2 times a day directly onto the scalp in the hairloss area. Using more or more often will not improve results. Do not apply on other parts of the body.
WARNINGS: Do not use if:
you have no family history of hairloss.
hairloss is sudden and/or patchy.
scalp is red, inflamed, infected, irritated or painful.
you do not know the reason for your hairloss.
you are under 18 years of age. Do not use on babies and children.
you use other topical prescription products on the scalp.
Stop use and see a doctor if you get:
chest pain, rapid heartbeat, faintness, or dizziness.
sudden unexplained weight gain.
swollen hands or feet.
redness or irritation.
Avoid contact with eyes. In case of accidental contact, rinse with large amounts of cool tap water.
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
Do not use if your hairloss is associated with childbirth.
Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Before use, read all label information.
Keep the carton. It contains important information.
INACTIVE
INGREDIENTS: Alcohol, 60% v/v, propylene glycol, and purified water.
Store at controlled room temperature 15 to 30 degrees C (59 to 86 degrees F).
00660396A1
Manufactured by
Barre-National Inc.
Baltimore, MD 21244
an Alpharma USPD company
[The following information is based on the consumer labeling leaflet in effect on June 25, 1996.]
MINOXIDIL
TOPICAL SOLUTION 2%
Important information about Minoxidil Topical Solution 2% for Men
Hair regrowth treatment
Previously available only by prescription
Minoxidil Topical Solution is the only product 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 doctor or pharmacist.
What is Minoxidil Topical Solution?
Minoxidil Topical Solution is a colorless 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 hairloss on the top of the head. The common hereditary thinning or hairloss process begins slowly and may become noticeable only after years of gradual loss.
Minoxidil Topical Solution is for men with hairloss 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 hairloss in the range shown below. If men have more hairloss than shown, minoxidil topical solution may not work.
Many of those experiencing hairloss have other family members with gradual thinning hair or hairloss.
If there is no family history of gradual thinning hair or gradual hairloss, or hairloss is patchy, talk to your doctor.
Who should NOT use Minoxidil Topical Solution?
Minoxidil Topical Solution will not prevent or improve hairloss 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 hairloss due to:
damage from the use of hair care products which cause scarring or deep burns of the scalp.
hair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp.
You should ask your doctor if you are unsure of the cause of your hairloss.
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 hairloss.
In clinical studies of mostly white men aged 18-49 years with moderate degrees of hairloss, the following response to Minoxidil Topical Solution was reported:
Male Response to Minoxidil Topical Solution
Percent reporting hair regrowth
26% of men reported moderate to dense hair regrowth after using Minoxidil Topical Solution for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth).
What Minimal, Moderate and Dense Hair Regrowth Will Mean For You
Can Minoxidil Topical Solution be used to prevent hairloss?
We do not know if Minoxidil Topical Solution will prevent hairloss.
How soon can I expect results from using Minoxidil Topical Solution?
Since normal hair usually grows only 1/2« 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 12 months, stop using Minoxidil Topical Solution and see your doctor.
When you first begin to use Minoxidil Topical Solution, your hairloss may continue for up to 2 weeks. This hairloss 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 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 hairloss 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 hairloss area TWO TIMES A DAY; for example, once in the morning and once at night. Each bottle should last about 25-30 days, 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 twice a day? Will it work faster, better?
No. Minoxidil Topical Solution will not work faster or better if used more than two 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.?
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?
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 off 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, as long as you use good judgment. 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 growth?
Unwanted hair growth elsewhere on the body has been reported. This may be due to the frequent applying of Minoxidil Topical Solution on the areas of the skin other than the scalp.
To prevent unwanted hair growth, limit the application of Minoxidil Topical Solution only to the scalp.
Can I use Minoxidil Topical Solution for baldness or hairloss in babies and children?
No. Minoxidil Topical Solution must not be used to treat baldness or hairloss in babies and children.
Are there any special warnings about the use of Minoxidil Topical Solution?
DO NOT USE Minoxidil Topical Solution AND SEE YOUR DOCTOR IF YOU:
Have no family history of hairloss
Have sudden hairloss
Have patchy hairloss
Do not know the reason for your hairloss
DO NOT USE Minoxidil Topical Solution IF YOU:
Are less than 18 years old
Have ever had an allergic reaction to Minoxidil Topical Solution
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
DO NOT APPLY Minoxidil Topical Solution ON SCALP IF THE SKIN IS:
Red or inflamed
Infected
Irritated
Painful to touch (such as severe sunburn)
STOP USING Minoxidil Topical Solution AND SEE YOUR DOCTOR IF YOU GET:
Chest pain
Rapid heartbeat
Faintness and/or dizziness
Sudden, unexplained weight gain
Swollen hands or feet
Redness or irritation on treated areas of your scalp
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:
Apply one mL 2 times a day directly onto the scalp in the hairloss area. Do not use more. Each bottle should last about 25-30 days, if used as directed. Use a mild shampoo if you wash your scalp before applying Minoxidil Topical Solution.
The applicator contains one dose of medicine. It is not necessary to use fingertips when applying Minoxidil Topical Solution. However, if you use your hands, wash them afterwards.
Do not take Minoxidil Topical Solution by mouth.
Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
If you have any other questions, ask your pharmacist.
Instruction for use of Applicator
The dropper can be useful for a broad range of hair styles or hairloss because it allows for easy application through the hair and directly onto the scalp.
Using the Applicator
DROPPER
The dropper is NOT child-resistant. If you have small children, keep the original child-resistant cap and place it back on the bottle after each use.
1. Squeeze the rubber bulb and insert the dropper into the bottle. Release the bulb, allowing the dropper to fill to the 1 mL line. If the level of the solution is above the 1 mL line, squeeze the extra amount back into the bottle.
2. Next, place the tip near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. To prevent the solution from running off the scalp, apply a small amount at a time.
Store at controlled room temperature 15 to 30 degrees C (59 to 86 degrees F).
Form 0066-4
Manufactured by
Barre-National Inc.
Baltimore, MD 21244
an Alpharma USPD company
Rev.3/96
