5% Minoxidil Topical Solution
FDA Label NDC 85174-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nanhong (zhuhai) Biotechnology Co., Ltd. for the product 5% Minoxidil Topical Solution (NDC 85174-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Storage And Handling

→ Inactive Ingredient

→ Package Label.principal Display Panel

Other

5% MINOXIDIL TOPICAL SOLUTION

Otc - Active Ingredient

MINOXIDIL 5%

Otc - Purpose

Hair regrowth treatment for men

Indications & Usage

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

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Otc - Do Not Use

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

Otc - When Using

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.

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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.