5% MINOXIDIL TOPICAL Solution

Manufacturer
Nanhong (Zhuhai) Biotechnology Co., Ltd.
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:52:50

Label at a glance#

Product5% MINOXIDIL TOPICAL Solution
Active ingredientMINOXIDIL
Label structure13 sections

Storage and handling

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)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

5% MINOXIDIL TOPICAL SOLUTION

OTC - ACTIVE INGREDIENT SECTION

MINOXIDIL 5%

OTC - PURPOSE SECTION

Hair regrowth treatment for men

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only. For use by men only.

Flammable: Keep away from fire or flame

OTC - DO NOT USE SECTION

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 SECTION

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 SECTION

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 SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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)

INACTIVE INGREDIENT SECTION

ALCOHOL
GLYCERIN
PROPYLENE GLYCOL
PURIFIED WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN1
311724minoxidil 50 MG/ML Topical SolutionSCD1
311724minoxidil 3 GM per 60 ML Topical SolutionSY1
311724minoxidil 5 % Topical SolutionSY1
311724minoxidil 5 GM per 100 ML Topical SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85174-001-025% MINOXIDIL TOPICAL Solution60 mL in 1 BOTTLESOLUTION601
85174-001-025% MINOXIDIL TOPICAL Solution2 in 1 PACKAGESOLUTION21
85174-001-035% MINOXIDIL TOPICAL Solution3 in 1 PACKAGESOLUTION31
85174-001-035% MINOXIDIL TOPICAL Solution60 mL in 1 BOTTLESOLUTION601
85174-001-045% MINOXIDIL TOPICAL Solution60 mL in 1 BOTTLESOLUTION601
85174-001-045% MINOXIDIL TOPICAL Solution4 in 1 PACKAGESOLUTION41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85174-0015% MINOXIDIL TOPICAL SOLUTION (MINOXIDIL) SOLUTION [NANHONG (ZHUHAI) BIOTECHNOLOGY CO., LTD.]16 package rows20250117_2bc9e626-3849-f927-e063-6394a90a5fee.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85174-00185174-001-02, 85174-001-03, 85174-001-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2bc9e626-384a-f927-e063-6394a90a5fee2bc9e626-3849-f927-e063-6394a90a5fee2025-01-15WarningsExact identifier
spl id: 2bc9e626-384a-f927-e063-6394a90a5fee
spl set id: 2bc9e626-3849-f927-e063-6394a90a5fee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.