SPL v1
SPL
SPL Set ID 3d5b004e-c721-a2fb-e063-6294a90ac39a
Route
TOPICAL
Published
Effective Date 2025-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Piroctone Olamine Reynoutria Multiflora Root Biotin Peg-40 Hydrogenated Castor Oil Butylene Glycol Propylene Glycol Phenoxyethanol Cnidium Monnieri Fruit Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-22

Description

Minoxidil 5% Hair regrowth treatment

Purpose

to regrow hair on the scalp to help reverse hereditary hair loss

Dosage and Administration

For external use only.


Medication Information

Purpose

to regrow hair on the scalp

to help reverse hereditary hair loss

Dosage and Administration

For external use only.

Description

Minoxidil 5% Hair regrowth treatment

Uses

to regrow hair on the scalp

to help reverse hereditary hair loss

Warnings

For external use only.

Flammable: Keep away from fire or flame

Stop Use

chest pain, rapid heartbeat, faintness, or dizziness occurs

sudden.unexplained weight gain occurs

your hands or feet swell

scalo irritation or redness occurs

unwanted facial hair growth occurs

you do not see hair regrowth in 4 months

Do Not Use

you have no family history of hair loss

your hairloss 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 painfulyou use other medicines on the scalp

Active Ingredients

Minoxidil 5% Hair regrowth treatment

When Using Section

do not apply on other parts of the body

avoid contact with the eyes. in case of accidental contact, rinse eyes with large amountsof 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 somemen, you mav need to use this product for at least 4 months before vou see results.

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

Inactive Ingredients

Aqua, Propylene Glycol, Butylene Glycol, PEG-40 Hydrogenated Castor Oil, Zingiber Officinale (Ginger) Extract, Fragrance, Polygonum Multiflorum Root Extract, Cnidium Monnieri Fruit Extract, Phenoxyethanol, Piroctone Olamine, Biotin

Principal Display Panel

Keep Out of Reach of Children.

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away.


Structured Label Content

Uses

to regrow hair on the scalp

to help reverse hereditary hair loss

Purpose

to regrow hair on the scalp

to help reverse hereditary hair loss

Warnings

For external use only.

Flammable: Keep away from fire or flame

Stop Use (stop use)

chest pain, rapid heartbeat, faintness, or dizziness occurs

sudden.unexplained weight gain occurs

your hands or feet swell

scalo irritation or redness occurs

unwanted facial hair growth occurs

you do not see hair regrowth in 4 months

Do Not Use (Do not use)

you have no family history of hair loss

your hairloss 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 painfulyou use other medicines on the scalp

Active Ingredients (Active ingredients)

Minoxidil 5% Hair regrowth treatment

When Using Section (When using section)

do not apply on other parts of the body

avoid contact with the eyes. in case of accidental contact, rinse eyes with large amountsof 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 somemen, you mav need to use this product for at least 4 months before vou see results.

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

Inactive Ingredients (Inactive ingredients)

Aqua, Propylene Glycol, Butylene Glycol, PEG-40 Hydrogenated Castor Oil, Zingiber Officinale (Ginger) Extract, Fragrance, Polygonum Multiflorum Root Extract, Cnidium Monnieri Fruit Extract, Phenoxyethanol, Piroctone Olamine, Biotin

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dosage and Administration (Dosage and administration)

For external use only.

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)