5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN- minoxidil aerosol, foam

5% Minoxidil Hair Growth Foam with Biotin by

Drug Labeling and Warnings

5% Minoxidil Hair Growth Foam with Biotin by is a Otc medication manufactured, distributed, or labeled by Jinan Guyun Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

5% Minoxidil Hair Growth Foam with Biotin

ACTIVE INGREDIENT

Minoxidil 5%
Biotin 0.5%

PURPOSE

Hair regrowth treatment for men and women

INDICATIONS & USAGE

Use to regrow hair of the scalp

WARNINGS

Flammable: keep away from fire or flame.

Keep out of reach of children.

For external use only

DO NOT USE

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.

WHEN USING

Do not apply on other parts of the body.

Avoid contact with the eyes. In case of accidental contact, rinse eyes with largeamounts 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 davusage, for some people, you may need to use this product for at least 4months before you see results.
The amount of hair regrowth is different for each person. This product willnot work for all people.

STOP USE

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,

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. lf swallowed, get medical help or contact
a Poison Control Center(1-800-222-1222)right away.

DOSAGE & ADMINISTRATION

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 leaflet 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 hairloss will begin again.

STORAGE AND HANDLING

Before use, read all information on carton and enclosed leaflet.Store at controlled room temperature 20° to 25°℃ (68° to 77°F)Do not incinerate container. Do not expose to heat or store at temperatureabove 104°F(40°C)

INACTIVE INGREDIENT

ALCOHOL
GLYCERIN
CETYL ALCOHOL
STEARYL ALCOHOL
POLYSORBATE 80
ANHYDROUS CITRIC ACID
LACTIC ACID
CASTOR OIL
EDETATE DISODIUM
ISOBUTANE
BUTANE
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN 
minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83988-002
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
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BUTANE (UNII: 6LV4FOR43R)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CASTOR OIL (UNII: D5340Y2I9G)
ALCOHOL (UNII: 3K9958V90M)
LACTIC ACID (UNII: 33X04XA5AT)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ISOBUTANE (UNII: BXR49TP611)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83988-002-01	2 in 1 PACKAGE	10/31/2024
1		60 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 83988-002-02	4 in 1 PACKAGE	10/31/2024
2		60 g in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 83988-002-03	6 in 1 PACKAGE	10/31/2024
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)	10/31/2024

Labeler - Jinan Guyun Technology Co., Ltd (544454964)

Establishment
Name	Address	ID/FEI	Business Operations
Jinan Guyun Technology Co., Ltd		544454964	manufacture(83988-002)