SPL v4
SPL
SPL Set ID 5d8460fc-cd6f-72af-e053-2a91aa0ad2f3
Route
TOPICAL
Published
Effective Date 2017-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Propylene Glycol Water Alcohol

Identifiers & Packaging

Marketing Status
ANDA Active Since 2017-11-01

Description

Minoxidil 5% w/v


Medication Information

Warnings and Precautions

For external use only



For use by men only



Flammable: Keep away from fire or flame



Do not use if

•you are a woman

•your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Solution, 5% is not intended for frontal baldness or receding hairline.

•you have no family history of hair loss

•your hair loss is sudden and/or patchy

•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



Ask a doctor before use if you have heart disease



When using this product

•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. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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 all men.



Stop use and ask a doctor if

•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



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.

Indications and Usage

to regrow hair on the scalp (vertex only, see picture on side of carton)

Dosage and Administration

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

Description

Minoxidil 5% w/v

Section 50565-1



Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

alcohol, propylene glycol, purified water

Section 51945-4

Section 53413-1

Questions or Comments: Call toll-free 1 (800) 368-0038 or Visit Website at www.forhims.com

Section 55105-1

Hair regrowth treatment for men

Section 55106-9

Minoxidil 5% w/v

Section 60561-8

• 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.

• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men

• in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

• store at controlled room temperature 20º to 25ºC (68º to 77ºF).


Structured Label Content

Indications and Usage (34067-9)

to regrow hair on the scalp (vertex only, see picture on side of carton)

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only



For use by men only



Flammable: Keep away from fire or flame



Do not use if

•you are a woman

•your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Solution, 5% is not intended for frontal baldness or receding hairline.

•you have no family history of hair loss

•your hair loss is sudden and/or patchy

•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



Ask a doctor before use if you have heart disease



When using this product

•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. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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 all men.



Stop use and ask a doctor if

•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



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.

Section 50565-1 (50565-1)



Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

alcohol, propylene glycol, purified water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments: Call toll-free 1 (800) 368-0038 or Visit Website at www.forhims.com

Section 55105-1 (55105-1)

Hair regrowth treatment for men

Section 55106-9 (55106-9)

Minoxidil 5% w/v

Section 60561-8 (60561-8)

• 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.

• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men

• in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

• store at controlled room temperature 20º to 25ºC (68º to 77ºF).


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