5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN- minoxidil liquid

5% Minoxidil Hair Regrowth Serum With Biotin by

Drug Labeling and Warnings

5% Minoxidil Hair Regrowth Serum With Biotin by is a Otc medication manufactured, distributed, or labeled by Guangzhou Ruijiu Electronic Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

5% Minoxidil Hair Regrowth Serum With Biotin

ACTIVE INGREDIENT

Minoxidil 5%
Biotin 0.5%

PURPOSE

Hair regrowth treatment

INDICATIONS & USAGE

Use to regrow hair on the scalp and promote beard growth for men.

WARNINGS

For extérnal use only.
Keep out of reach of children.

DO NOT USE

You have no family history of hair loss.
Your halr 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 eyes.In case of accidental contact, rinse eyeswith a large amountof cool tap water.
You need fo use this product once a day for best results.Theamount of hair regrowth varies for each person.

STOP USE

lf chest pain, rapid heartbeat, faintness, or dizziness occurs.
lf sudden,unexplained weight gain occurs.
lf your hands or feet swell.
if scalp irritation or redness occurs.
lf you get unwanted facial hair growth occurs.
lf you do not see hair regrowth in 4 months.

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

Apply3-6 drops Minoxidil Serum directly onto scalp on the hair loss area,(3-4 drops for women, 5-6 drops for men).
Massage with your hands for 1 minute. After massaging, wash your hands thoroughly.
Used once daily on clean dry hair for best results.

STORAGE AND HANDLING

Before use, read all information on carton and enclosed leaflet.Store at controlled room temperature 10'C to 25°℃ (50°F to 77°F)Do not incinerate container. Do not expose to heat or store attemperature above 104°F(40°C)

INACTIVE INGREDIENT

Alcohol
Panthenol
Glycerin
Anhydrous citric acid
Polysorbate 60
Carbomer homopolymer
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN 
minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83767-401
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 mL
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PANTHENOL (UNII: WV9CM0O67Z)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83767-401-01	1 in 1 PACKAGE	08/20/2024
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 83767-401-02	2 in 1 PACKAGE	08/20/2024
2		100 mL 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)	08/20/2024

Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Ruijiu Electronic Technology Co., Ltd.		631973699	manufacture(83767-401)