5%Minoxidil HAIR REGROWTH

Manufacturer
Shenzhen Zhumeng Times Technology Co., Ltd.
Effective date
2024-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:23

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Minoxidil 5%

Purpose

Halr regrowth treatment for men

Uses

Uses

wet hair to be cleansed apply soap and gently massage area for 1-2 minutes rinse thoroughly and pat dry

Warnings

Warnings

For external use only Do not use if You have no famlly history of hair loss 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 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 heart disease

Do not use

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

Directions And Dosage

Dosage and administration

For external use only.

Other Label Information

Inactive ingredients

Sodium stearate,POLYGONUM MULTIFLORUM EXTRACT,TEA-Lauroyl Glutamate,HYDROGENATED OLIVE OIL,HYDROGENATED COCONUT OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,PANAX GINSENG EXTRACT,BIOTA ORIENTALIS LEAF EXTRACT,Curcuma Longa (Turmeric) Root Oil,SODIUM HYALURONATE

PRINCIPAL DISPLAY PANEL

Label Images#

84369-003-01
84369-003-01

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84372-003-012025-07-29C16284748780-13b156c62-2882-fb37-e063-e6dba90a4e072004ffcb-3bed-5a4e-e063-6294a90ab00d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84372-003-015%Minoxidil HAIR REGROWTH60 g in 1 BOXLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84372-0035%MINOXIDIL HAIR REGROWTH LIQUID [SHENZHEN ZHUMENG TIMES TECHNOLOGY CO., LTD.]11 package rows20240820_2004ffcb-3bed-5a4e-e063-6294a90ab00d.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84372-00384372-003-01

Ingredients#

Complete SPL Sections#

Active ingredients

COMPONENTS

Minoxidil 5%

Purpose

OTC - PURPOSE SECTION

Halr regrowth treatment for men

Uses

INDICATIONS & USAGE SECTION

wet hair to be cleansed apply soap and gently massage area for 1-2 minutes rinse thoroughly and pat dry

Warnings

WARNINGS SECTION

For external use only Do not use if You have no famlly history of hair loss 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 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 heart disease

Dosage and administration

DOSAGE & ADMINISTRATION SECTION

For external use only.

Do not use

OTC - DO NOT 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 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. Keep out of reach of children, lf swallowed, get medical help or contact a Poison Control Center right away.

When using section

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 notwork for all men.

stop use

OTC - STOP USE SECTION

on broken or irritated scalp

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If sxralowed, get medical help or contact a Poison Conirol Cenler ngiht away.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium stearate,POLYGONUM MULTIFLORUM EXTRACT,TEA-Lauroyl Glutamate,HYDROGENATED OLIVE OIL,HYDROGENATED COCONUT OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,PANAX GINSENG EXTRACT,BIOTA ORIENTALIS LEAF EXTRACT,Curcuma Longa (Turmeric) Root Oil,SODIUM HYALURONATE

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML