81653-013 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 18:02:32

Label at a glance#

ProductSOTI HAIR GROWTH SERUM
Active ingredientMINOXIDIL
Label structure8 sections

Dosage and administration

■ Apply 1 ml twice a day directly onto the scalp in the hair loss area ■ massage into scalp with fingers, then wash hands well ■ 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

keep the carton. t contains important information. store at 20° to 25°C (68°to 77°F). Keep tightly closed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

Use

INDICATIONS & USAGE SECTION

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Purpose

OTC - PURPOSE SECTION

Hair Growth Serum for people

Warnings

WARNINGS SECTION

For external use only
Flammable:
Keep away from fire or flame

Do not use if

OTC - DO NOT USE SECTION

■ our amount of hair loss is different than that shown the side of this carton or your hair loss is on the front of the scalp. Hair Growth Serum is not intended for frontal baldness or receding hairline

■ you have no family history of hair loss

■ your hair loss is sudden and/or patch

■ 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease

When using this product

OTC - 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 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 people, you may 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 people

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

■ sudden, unexplained weight gain occurs

■ your hands or feet swell

■ scalp irritation or redness occurs

■ unwanted facial hair growth occurs

■ you do not see hair regrowth in 4 months

May be harmful if used when pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

Other information

STORAGE AND HANDLING SECTION

keep the carton. t contains important information.
store at 20° to 25°C (68°to 77°F). Keep tightly closed.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Apply 1 ml twice a day directly onto the scalp in the hair loss area

■ massage into scalp with fingers, then wash hands well

■ 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

Ingredients

INACTIVE INGREDIENT SECTION

Reynoutria Multiflora Whole

Angelica Sinensis Whole

Biotin

Platycladus Orientalis Leaf

Asian Ginseng

Carthamus Tinctorius Whole

Dictamnus Dasycarpus Root Bark

Ligustrum Lucidum Fruit

Alcohol

Ligusticum Sinense Subsp. Chuanxiong Root

Glycyrrhiza Uralensis Whole

Capsaicin

MARINE COLLAGEN SOLUBLE

Ginger

Arctium Lappa Whole

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN4
311724minoxidil 50 MG/ML Topical SolutionSCD4
311724minoxidil 3 GM per 60 ML Topical SolutionSY4
311724minoxidil 5 % Topical SolutionSY4
311724minoxidil 5 GM per 100 ML Topical SolutionSY4

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
QR code linkQR Codewww.trycrystalclear.com/60ml.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81653-013-012025-02-09C16284748780-12cef2736-9525-d83d-e063-dadaa90ab31f81653-013 Update 505G
81653-013-012025-01-30C16284748780-12cef2736-9525-d83d-e063-dadaa90ab31f81653-013 Update 505G

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81653-013-01SOTI HAIR GROWTH SERUM60 mL in 1 BOTTLELIQUID604

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81653-01381653-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
SOTI HAIR GROWTH SERUMMINOXIDILGuangzhou Jianyuan Biological Technology Co., Ltd.0d8beb7c-48be-54de-e063-6394a90a41492026-05-24WarningsExact identifier
ndc (package): 81653-013-01
ndc (product): 81653-013
ndc11 (package): 81653001301
spl id: 529d33c1-574b-29bc-e063-6294a90a3474
spl set id: 0d8beb7c-48be-54de-e063-6394a90a4149

Reported adverse events (FAERS/openFDA)#

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