5% Minoxidil Topical Solution

5% Minoxidil Topical Solution
SPL v1
SPL
SPL Set ID 2bc9e626-3849-f927-e063-6394a90a5fee
Route
TOPICAL
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Glycerin Alcohol Water Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-16

Description

5% MINOXIDIL TOPICAL SOLUTION


Medication Information

Warnings and Precautions

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Indications and Usage

to regrow hair on the top of the scalp (vertex onlysee pictures on side of carton)

Dosage and Administration

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

using more or more often will not improve results

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

Description

5% MINOXIDIL TOPICAL SOLUTION

Section 42229-5

5% MINOXIDIL TOPICAL SOLUTION

Section 44425-7

see hair loss pictures on side of this carton

before use, read all information on carton

keep the carton. lt contains important information.

5% minoxidil topical solution for men provided more hairregrowth than 2% minoxidil topical solution

store at controlled room temperature 20° to 25°C(68° to 77°F)

Section 50565-1

May be harmful if used when pregnant or breast-feeding.Keep out of reach of children. lf swallowedget medical help or contact a Poison Control Centerright away.

Section 50566-9

chest pain, rapid hearbeat, faintness, or dizziness occurs

sudden, unexplained weight gain occurs

your hands or feet swell

scalp irritation or redness occurs

unwanted facial hair growth occursyou do not see hair regrowth in 4 months

Section 50567-7

do not apply on other parts of the body

avoid contact with the eyes. In case of accidental contactrinse 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 2months with twice a day usage. For some men, you mayneed to use this product for at least 4 months before yousee results.

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

Section 50570-1

you are a woman

your amount of hair loss is different than that shown onthe side of this carton, or your hair loss is on the front ofthe scalp.5% minoxidil topical solution is not intended forfrontal baldness or receding hairline.

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 babiesand children.

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

you use other medicines on the scalp

Section 51727-6

ALCOHOL

GLYCERIN

PROPYLENE GLYCOL

PURIFIED WATER

Section 51945-4

Section 55105-1

Hair regrowth treatment for men

Section 55106-9

MINOXIDIL 5%


Structured Label Content

Indications and Usage (34067-9)

to regrow hair on the top of the scalp (vertex onlysee pictures on side of carton)

Dosage and Administration (34068-7)

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

using more or more often will not improve results

continued use is necessary to increase and keep yourhair 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

Section 42229-5 (42229-5)

5% MINOXIDIL TOPICAL SOLUTION

Section 44425-7 (44425-7)

see hair loss pictures on side of this carton

before use, read all information on carton

keep the carton. lt contains important information.

5% minoxidil topical solution for men provided more hairregrowth than 2% minoxidil topical solution

store at controlled room temperature 20° to 25°C(68° to 77°F)

Section 50565-1 (50565-1)

May be harmful if used when pregnant or breast-feeding.Keep out of reach of children. lf swallowedget medical help or contact a Poison Control Centerright away.

Section 50566-9 (50566-9)

chest pain, rapid hearbeat, faintness, or dizziness occurs

sudden, unexplained weight gain occurs

your hands or feet swell

scalp irritation or redness occurs

unwanted facial hair growth occursyou do not see hair regrowth in 4 months

Section 50567-7 (50567-7)

do not apply on other parts of the body

avoid contact with the eyes. In case of accidental contactrinse 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 2months with twice a day usage. For some men, you mayneed to use this product for at least 4 months before yousee results.

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

Section 50570-1 (50570-1)

you are a woman

your amount of hair loss is different than that shown onthe side of this carton, or your hair loss is on the front ofthe scalp.5% minoxidil topical solution is not intended forfrontal baldness or receding hairline.

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 babiesand children.

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

you use other medicines on the scalp

Section 51727-6 (51727-6)

ALCOHOL

GLYCERIN

PROPYLENE GLYCOL

PURIFIED WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment for men

Section 55106-9 (55106-9)

MINOXIDIL 5%


Advanced Ingredient Data


Raw Label Data

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