5% MINOXIDIL HAIR REGROWTH FOAM- minoxidil aerosol, foam

5% Minoxidil Hair Regrowth Foam by

Drug Labeling and Warnings

5% Minoxidil Hair Regrowth Foam by is a Otc medication manufactured, distributed, or labeled by Lianjiang Shanlilai E-commerce Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

5% Minoxidil Hair Regrowth Foam

ACTIVE INGREDIENT

Minoxidil 5%
Biotin 0.5%

PURPOSE

Hair regrowth treatment

INDICATIONS & USAGE

Use to regrow hair on the top of the scalp

WARNINGS

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

DO NOT USE

you are a woman.
your amount of hair loss is different than that shown on side ofthis carton or your hair loss is on the front of the scalp.5% minoxidilfoam is not intended for frontal baldness or receding hairline.
You have no family history of hair loss.
Your hair loss is sudden andjor 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.
You use other medicines on the scalp.
Your scalp is red, inflamed, infected, irritated, or painful.

WHEN USING

Do not apply on other parts of the body.
Avoid contact with the eyes. in case of accidental contact, rinseeyes with large amounts of cool tap water.
Some people have experienced changes in hair color and,;or textureit takes time to regrow hair, Results may occur at 3 months withtwice a day usage. For some men, you may need to use this productfor at least 6 months before you see results.
The amount of hair regrowth is different for each person.This product will not work for all men.

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.

KEEP OUT OF REACH OF CHILDREN

lf swallowed, get medical help or contact a Poison ControlCenter right away.(1-800-222-1222)right away.

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 lossarea.
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.

STORAGE AND HANDLING

Before use, read all information on carton and enclosed leaflet

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Do not incinerate container. Do not expose to heat or store attemperature above 120°F(49°C).

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL HAIR REGROWTH FOAM 
minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85038-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 g
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LACTIC ACID (UNII: 33X04XA5AT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALCOHOL (UNII: 3K9958V90M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CASTOR OIL (UNII: D5340Y2I9G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85038-003-01	1 in 1 PACKAGE	12/11/2024
1		60 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 85038-003-02	2 in 1 PACKAGE	12/11/2024
2		60 g in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 85038-003-03	3 in 1 PACKAGE	12/11/2024
3		60 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	12/11/2024

Labeler - Lianjiang Shanlilai E-commerce Co., Ltd. (638192827)

Establishment
Name	Address	ID/FEI	Business Operations
Lianjiang Shanlilai E-commerce Co., Ltd.		638192827	manufacture(85038-003)