FLUMISCH 5% MINOXIDIL- 5% minoxidil aerosol, foam

FluMisch 5% Minoxidil by

Drug Labeling and Warnings

FluMisch 5% Minoxidil by is a Otc medication manufactured, distributed, or labeled by Beijing JUNGE Technology Co., Ltd., Zhejiang Ayan Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALARMS

For external use only.

Extremely Flammable: Avoid fire, flame, or smoking during andimmediately following application.

KEEP OUT OF REACH OF CHILDREN

swallowed, get medical help or contact a Poison Control Center rightaway.(1-800-222-1222)right away.

INACTIVE INGREDIENT

ALCOHOL
GLYCERIN
CETYL ALCOHOL
STEARYL ALCOHOL
POLYSORBATE 80
ANHYDROUS CITRIC ACID
LACTIC ACID
CASTOR OIL
.ALPHA.-TOCOPHEROL
EDETATE DISODIUM
WATER

DOSAGE & ADMINISTRATION

See enclosed leaflet for complete directions on how to use.
Apply half a capful twice daily directly to 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 regrowthor hair loss will begin again.

WHEN USING

Do not use more than directed.

Do not apply on other parts of the body.

Avoid contact with the eyes, In case of accidental contact, rinse eyeswith large amounts of cool tap water.

For some women, you may need to use this product once a day forat least 6 months before you see results.

The amount of hair regrowth is different for each person. Thisproduct will not work for all women,

STOP USE

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

if sudden, unexplained weight gain occurs.

if your hands or feet swell.

if scalp irritation or redness occurs.

if unwanted facial hair growth occurs .

if you do not see hair regrowth in 6 months.

DO NOT USE

your degree of hair loss is different than that shown on side of thiscarton because this product may not work for you.

You have no family history of hair loss.

Your hair loss is sudden and/or patchy.

You do not know the reason for your hair loss.

Your hair loss is associated with childbirth.

You are under 18 years of age, Do not use on babies and children,

You use other medicines on the scalp.

Your scalp is red, inflamed, infected, irritated, or painful.

ACTIVE INGREDIENT

Minoxidil 5% Biotin 5%

WARNINGS

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

INDICATIONS & USAGE

Use to regrow hair on the top of the scalp

PURPOSE

Hair regrowth treatment

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLUMISCH 5% MINOXIDIL 
5% minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85212-0034
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	5 g  in 100 mL
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LACTIC ACID (UNII: 33X04XA5AT)	1 mL  in 100 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	1 mL  in 100 mL
CASTOR OIL (UNII: D5340Y2I9G)	1 mL  in 100 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	1 mL  in 100 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	83 mL  in 100 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	1 mL  in 100 mL

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85212-0034-1	1 mL in 1 BOX; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075357	01/01/2025

Labeler - Beijing JUNGE Technology Co., Ltd. (848718652)

Registrant - Beijing JUNGE Technology Co., Ltd. (848718652)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co., Ltd.		544377996	manufacture(85212-0034)