​81653-005 Update 505G

Manufacturer
Guangzhou Jianyuan Biological Technology.Co.,Ltd
Effective date
2026-05-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-zip
Hydrated at
2026-05-27 18:02:36

Label at a glance#

ProductHair regrowth treatment
Active ingredientMINOXIDIL
Label structure13 sections

Storage and handling

store at controlled room temperature 20° to 25C (68° to 77°F) contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store attemperatures above 120°F(49°c) lngredients

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

OTC - PURPOSE SECTION

Use to regrow hair on the top of the scalp (vertex only)

INDICATIONS & USAGE SECTION

Remixidil Foam is for some people who have a general thinning of hair on the top of the scalp (vertex only, as shownbelow). Not intended for frontal baldness or a receding hairline. Remixidil Foam has been shown to regrow hair in some people with the following degrees of thinning hair or hair loss.

usageusage

WARNINGS SECTION

For external use only.
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

May be harmful if used when pregnant or breast-feeding.

OTC - STOP USE SECTION

Stop use and ask a doctor if
chest pain, rapid heartbeat, faintness, or dizziness occurs
sudden unexplained weight gain occurs
your hands or feet swell
scalp irritation or redness occursunwanted facial hair growth occurs
you do not see hair regrowth in 4 months

Ask a doctor before use if you have heart disease

WARNINGS AND PRECAUTIONS SECTION

When using this product
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. Results may occur at 2 months with twice a day usage.For some men, youmay need to use this product for at least 4 months before you see results.
the amount of hair regrowth is different for each person. This product will not work for all men and women

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

apply half a capful 2 times a day to the scalp in the hair loss area
massage into scalp with fingers then wash hands well
see enclosed booklet for complete directions on how to use
using more or more often will not improve results
continued use is necessary to increase and keep your hair regrowth or hair loss will begin again

STORAGE AND HANDLING SECTION

store at controlled room temperature 20° to 25C (68° to 77°F)
contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store attemperatures above 120°F(49°c)
lngredients

OTHER SAFETY INFORMATION

before use, read all information on carton and enclosed leafletkeep the package, It contains important information

lnactive ingredients

INACTIVE INGREDIENT SECTION

Water, Polygonum multiflorum Thunb, Angelica Sinensis, Vitamin H.(Biotin), Cacumen Platycladi Orientalis, Ginseng Extract, Carthamus tinctorius L. Extract, Cortex Dictamni , Fructus Ligustri Lucidi Extract , Alcohol, Ligusticum Chuanxiong Hort Extract, Glycyrrhiza uralensis Fisch Extract, Capsaicin

Hair regrowth treatment for Men

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

111111

Hair regrowth treatment for Women

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

000000

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
645146minoxidil 5 % Topical FoamPSN4
645146minoxidil 50 MG/ML Topical FoamSCD4
645146minoxidil 5 % Topical FoamSY4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-134607086410639GTIN-13: 4607086410639
EAN-13: 4607086410639
GTIN storage (14 digits): 04607086410639
1667197504712.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81653-005-01Hair regrowth treatment3 in 1 BOXLIQUID34
81653-005-01Hair regrowth treatment60 mL in 1 BOTTLE, SPRAYLIQUID604
81653-005-02Hair regrowth treatment60 mL in 1 BOTTLE, SPRAYLIQUID604
81653-005-02Hair regrowth treatment3 in 1 BOXLIQUID34

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81653-00581653-005-01, 81653-005-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Hair regrowth treatmentMINOXIDILGuangzhou Jianyuan Biological Technology.Co.,Ltdeb87ff2d-7708-4c4d-e053-2a95a90ac72b2026-05-24WarningsExact identifier
ndc (package): 81653-005-01
ndc (package): 81653-005-02
ndc (product): 81653-005
ndc11 (package): 81653000502
ndc11 (package): 81653000501
spl id: 529d3660-75b4-6036-e063-6294a90a3170
spl set id: eb87ff2d-7708-4c4d-e053-2a95a90ac72b

Reported adverse events (FAERS/openFDA)#

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