85038-007 Minoxidil Hair Regrowth Solution

85038-007 Minoxidil Hair Regrowth Solution
SPL v1
SPL
SPL Set ID 384db88f-95fc-3642-e063-6394a90a9123
Route
TOPICAL
Published
Effective Date 2025-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Glycerin Castor Oil Alcohol Cetyl Alcohol Water Biotin Lactic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-24

Description

Minoxidil 5%


Medication Information

Warnings and Precautions



For external use only.

Flammable: Keep away from fire or flame

Indications and Usage

Uses to regrow hair on the top of the scalp

Dosage and Administration



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

massageinto scalp with fingers, then wash hands well.

using more or more often will notimprove results.

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

Description

Minoxidil 5%

Section 50565-1

Keep out of reach of children. lfswallowed, get medical help or contact a Poison Control Centerright away.(1-800-222-1222)

Section 50566-9



chest pain,rapid heartbeat,faintness, or dizziness occurs.

sudden, unexplained weight gain occurs.

your hands or feet swel.

scalp irritation or redness occurs.

unwanted facial hair growth occurs.

you 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 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 monthspefore you see results.

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

Section 50570-1



your degree of hair loss is different than that shown on side of this carton ,because this product may not work for you.

you have no family history of hair loss.

your hairloss is sudden and/or patchy.

your hairloss 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.

Section 51727-6

biotin

castor oil

alcohol

glycerin

cetyl alcohol

lactic acid

water

Section 51945-4

Section 55105-1

Hair regrowth treatment

Section 55106-9

Minoxidil 5%


Structured Label Content

Indications and Usage (34067-9)

Uses to regrow hair on the top of the scalp

Dosage and Administration (34068-7)



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

massageinto scalp with fingers, then wash hands well.

using more or more often will notimprove 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.

Flammable: Keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children. lfswallowed, get medical help or contact a Poison Control Centerright away.(1-800-222-1222)

Section 50566-9 (50566-9)



chest pain,rapid heartbeat,faintness, or dizziness occurs.

sudden, unexplained weight gain occurs.

your hands or feet swel.

scalp irritation or redness occurs.

unwanted facial hair growth occurs.

you 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 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 monthspefore you see results.

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

Section 50570-1 (50570-1)



your degree of hair loss is different than that shown on side of this carton ,because this product may not work for you.

you have no family history of hair loss.

your hairloss is sudden and/or patchy.

your hairloss 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.

Section 51727-6 (51727-6)

biotin

castor oil

alcohol

glycerin

cetyl alcohol

lactic acid

water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment

Section 55106-9 (55106-9)

Minoxidil 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)