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

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.
Your hair loss is associated with childbirth.
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

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.
lt takes time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, you may need touse this product for at least 6 months before you see results. The amount of hair regrowth is different for each person.
Avoid contact with eyes, in case of accidental contact, rinse eyes with a large amount of cool tap water.

STOP USE

Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs.
lf unwanted facial hair growth occurs .
lf you do not see hair regrowth in 6 months.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

1.Hold the bottle upside down and gently press the valve to dispense foam onto your hand or a cold surface,approximately half a capful in size.
2.Massage the foam into your scalp with your fingers, parting your hair into rows to ensure even applicationto areas of thinning hair. Finally, wash your hands thoroughly.

3.Use Twice Daily and enjoy thicker, fuller hair growth in as little as 3 to 6 months.

STORAGE AND HANDLING

Before use, read all information on the carton and the enclosed leaflet.

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

Do not incinerate the container. Do not expose it to heat or store it at temperatures above 40°C (104°F)

INACTIVE INGREDIENT

cetyl alcohol
citric acid
glycerin
isobutane
lactic acid
polysorbate 60
purified water
SD alcohol
stearyl alcohol
butane
edetate disodium

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: 83988-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID (UNII: 2968PHW8QP)
LACTIC ACID (UNII: 33X04XA5AT)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTANE (UNII: 6LV4FOR43R)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOBUTANE (UNII: BXR49TP611)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83988-003-01	4 in 1 PACKAGE	12/12/2024
1		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)	12/12/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Jinan Guyun Technology Co., Ltd		544454964	manufacture(83988-003)