HERS MINOXIDIL- minoxidil solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)
Available from:
Hims, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Hair regrowth treatment to regrow hair on the scalp
Authorization status:
Abbreviated New Drug Application
Authorization number:
71730-202-16

HERS MINOXIDIL- minoxidil solution

Hims, Inc.

----------

HERS Minoxidil Topical Solution USP, 2% Drug Facts

Active ingredient

Minoxidil 2% w/v

Purpos e

Hair regrowth treatment

Us e

to regrow hair on the scalp

Warnings

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

your degree of hair loss is different than that shown on the side of this carton, because this

product may not work for you

you have no family history of hair loss

your hair loss is sudden and/or patchy

your hair loss is associated with childbirth

you do not know the reason for your hair loss

you are under 18 years of age. Do not use on babies and children.

your scalp is red, inflamed, infected, irritated, or painful

you use other medicines on the scalp

do not apply on other parts of the body

avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool

tap water.

some people have experienced changes in hair color and/or texture

it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months

before you see results.

the amount of hair regrowth is different for each person. This product will not work for

everyone.

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Other information

Inactive ingredients

alcohol, propylene glycol, purified water

Questions or comments?

Call toll-free 1-800-368-0038 or Visit Website at www.forhers.com

Consumer Information

IMPORTANT INFORMATION ABOUT

hers

Minoxidil Topical Solution USP 2%

hair regrowth treatment

for women

Unscented

chest pain, rapid heartbeat, faintness, or dizziness occurs

sudden, unexplained weight gain occurs

your hands or feet swell

scalp irritation or redness occurs

unwanted facial hair growth occurs

you do not see hair regrowth in 4 months

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area

using more or more often will not improve results

continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

see hair loss pictures on side of this carton

before use, read all information on carton and enclosed leaflet

keep the carton. It contains important information.

in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair

loss, the following response to minoxidil topical solution 2% was reported: 19% of women

reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had

moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting

moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months

(7% had moderate regrowth; 33% had minimal regrowth).

store at 20 to 25 C (68 to 77 F). Keep tightly closed.

Over 30 million American women experience hair thinning or hair loss, so you're not alone.

Minoxidil topical solution 2% contains the only ingredient that is medically proven effective to help

regrow hair in women.

Clinically proven to help regrow hair.

Reactivates hair follicles to stimulate regrowth.

Previously available only by prescription

SAVE THIS LEAFLET FOR FUTURE REFERENCE

Please read this leaflet carefully. It will help you understand how to use minoxidil topical solution 2%

and what to expect from its use. If you have any questions after reading this leaflet, or anytime while

using minoxidil topical solution 2%, you should ask your health care professional or call us at 1-800-

368-0038 or Visit Website at www.forhers.com.

What is minoxidil topical solution 2%?

Minoxidil topical solution 2% is a colorless liquid medication for use only on the top of the scalp to

help regrow hair.

Who may use minoxidil topical solution 2%?

Minoxidil topical solution 2% 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 2% is for general thinning of hair on the top of the scalp as shown. Minoxidil

topical solution 2% has been shown to regrow hair in women with the degrees of hair loss shown. If

women have more hair loss than shown, minoxidil topical solution 2% 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 2%?

Minoxidil topical solution 2% will not prevent or improve hair loss related to pregnancy, the use of

some prescription and non-prescription medications, certain severe nutritional problems (very low body

iron; excessive vitamin A intake), the recently discontinued use of birth control pills, low thyroid states

(hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp. Also, minoxidil topical

solution 2% will not improve hair loss 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.

Do not use minoxidil topical solution 2% if hair loss is patchy as shown below.

You should ask your doctor if you are unsure of the cause of your hair loss.

Will minoxidil topical solution 2% work for me?

The amount of hair regrowth is different for each person. Not everyone will respond to minoxidil

topical solution 2%. The response to minoxidil topical solution 2% cannot be predicted. No one will be

able to grow back all their hair.

In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss,

the following response to minoxidil topical solution 2% was reported:

FEMALE RESPONSE TO

MINOXIDIL TOPICAL

SOLUTION 2%

Percent reporting hair growth

19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months

(19% had moderate regrowth, 40% had minimal regrowth). This compares with 7% of women reporting

moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had

a moderate regrowth, 33% had minimal regrowth).

What Minimal, Moderate and Dense Hair Regrowth Will Mean For You

Number of Hairs

Hair Density

Some new hairs are seen, but not enough to cover

thinning areas.

Hairs in thinning areas do not

grow as closely together as hairs

on the rest of the head.

New hairs cover some or all of thinning areas.

Hairs in the thinning areas grow

more closely together, but are

not as close together as hairs on

the rest of the head.

New hairs cover, or almost completely cover,

thinning areas.

Hairs in thinning areas grow as

closely together as hairs on the

Minimal

Moderate

Dense

rest of head.

Can minoxidil topical solution 2% be used to prevent hair loss?

We do not know if minoxidil topical solution 2% will prevent hair loss.

How soon can I expect results from using minoxidil topical solution 2%?

Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with minoxidil topical

solution 2% also takes time. Generally new hair growth is slow for a minoxidil topical solution 2%

user. Continued use of 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 2% and see your

doctor.

When you first begin to use minoxidil topical solution 2%, 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 2% is working, what will the hair look like?

At first, hair growth may be soft, downy, colorless hairs. After further use, the new hairs should be the

same color and thickness as the other hairs on your scalp.

How long do I need to use minoxidil topical solution 2%?

If you respond to minoxidil topical solution 2%, you will need to use it 2 times a day to keep and

continue the hair regrowth. Up to 8 months of usage may be needed to see your best results from

minoxidil topical solution 2%.

What happens if I completely stop using minoxidil topical solution 2%? Will I keep the new hair?

Continuous use of minoxidil topical solution 2% is needed to maintain hair regrowth. If you stop using

minoxidil topical solution 2%, 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 2%?

You should apply a dose (1 mL) of minoxidil topical solution 2% 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 2%?

If you miss one or two daily doses of minoxidil topical solution 2%, just continue with your next dose.

You should not make up for missed doses.

Can I use minoxidil topical solution 2% more than two times a day? Will it work faster, better?

No. Minoxidil topical solution 2% 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 2%

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 chances of side effects.

What are the most common side effects with minoxidil topical solution 2%?

The most common side effects are itching and other skin irritations of the treated area of the scalp.

Minoxidil topical solution 2% contains alcohol, which would cause burning or irritation of the eyes or

sensitive skin areas. If minoxidil topical solution 2% 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 2%?

If you wash your scalp before applying minoxidil topical solution 2%, use a mild shampoo.

Dense

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 2%.

However, you should apply minoxidil topical solution 2% 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

2%?

Yes. We have no information that these treatments change the effect of minoxidil topical solution 2%.

However, to avoid possible scalp irritation, you should make sure all of the minoxidil topical solution

2% has been washed off the hair and scalp before using these chemicals.

Can I apply minoxidil topical solution 2% and wash my hair an hour later?

No. For minoxidil topical solution 2% to work best, you should allow minoxidil topical solution 2% 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 2%. If possible, apply minoxidil topical solution

2% 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 2%.

Can minoxidil topical solution 2% 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 2% 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 2%.

If you experience unwanted hair, discontinue using minoxidil topical solution 2% and see your doctor

for recommendations about appropriate treatment. After stopping use of minoxidil topical solution 2%,

the unwanted hair, if caused by the use of minoxidil topical solution 2%, should go away over time.

You can take steps to decrease the chances for unwanted hair growth:

1) limit the application of minoxidil topical solution 2% only to the scalp, 2) if you use your hands to

apply minoxidil topical solution 2%, 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 2%.

Can I use minoxidil topical solution 2% for baldness or hair loss in babies and children?

No. Minoxidil topical solution 2% 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 2%?

For external use only

Flammable: Keep away from fire or flame

Do not use if

your degree of hair loss is more than that shown on the other side of this leaflet, because this

product may not work for you

you have no family history of hair loss

your hair loss is sudden and/or patchy

your hair loss is associated with childbirth

you do not know the reason for your hair loss

you are under 18 years of age. Do not use on babies and children.

Ask a doctor before use if you have heart disease.

When using this product

Stop use and ask a doctor if

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away. (1-800-222-1222)

What factors may increase the risk of serious side effects with minoxidil topical solution 2%?

Minoxidil topical solution 2% 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

1) Remove the cap. To remove, push down and turn in direction of the arrows on the cap.

2) Part your hair in the area of hair thinning/loss. Follow the instructions below for using the dropper

applicator and apply one mL 2 times a day directly onto the scalp in the hair loss area. Do not use more.

Spread the liquid evenly over the hair loss area. If you use your fingers, wash hands with soap and

water immediately. Each bottle should last about one month, if used as directed. Use a mild shampoo if

you wash your scalp before applying minoxidil topical solution 2%.

your scalp is red, inflamed, infected, irritated, or painful

you use other medicines on the scalp

do not apply on other parts of the body

avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool

tap water.

some people have experienced changes in hair color and/or texture

it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months

before you see results.

the amount of hair regrowth is different for each person. This product will not work for

everyone.

chest pain, rapid heartbeat, faintness, or dizziness occurs

scalp irritation or redness occurs

sudden, unexplained weight gain occurs

unwanted facial hair growth occurs

your hands or feet swell

you do not see hair regrowth in 4 months

Using the Dropper Applicator

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 of the dropper 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.

3) After each use attach the dropper to the bottle to make it child-resistant by turning it clockwise until

tightly closed.

If you have any other questions, ask your health care professional or call us at 1-800-368-0038 or

Visit Website at www.forhers.com.

Store at 20º to 25ºC (68º to 77ºF).

Keep tightly closed.

Save this leaflet for future reference.

Made in Israel

Distributed by Hims, Inc.

San Francisco, CA 94107

forhers.com

Rev 10-19

: 20200 7K J3

Package/Label Principal Display Panel

hers

minoxidil topical solution usp, 2% hair regrowth treatment for women

Dermatologist Recommended #1 Active Ingredient

Reactivates hair follicles to stimulate regrowth.

Clinically proven to help regrow hair.

Topical Solution

Unscented

one month supply

ONE 60 mL (2 FL OZ) BOTTLE

HERS MINOXIDIL

minoxidil solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71730 -20 2

Route of Administration

TOPICAL

Hims, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MINO XIDIL (UNII: 59 6 5120 SH1) (MINOXIDIL - UNII:59 6 5120 SH1)

MINOXIDIL

2 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71730 -20 2-16

1 in 1 CARTON

0 2/18 /20 19

1

6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 75357

0 2/18 /20 19

Labeler -

Hims, Inc. (080696472)

Revised: 11/2019

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