5% MINOXIDIL HAIR REGROWTH SOLUTION WITH BIOTIN- minoxidil solution

5% Minoxidil Hair Regrowth Solution With Biotin by

Drug Labeling and Warnings

5% Minoxidil Hair Regrowth Solution 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 Solution With Biotin

ACTIVE INGREDIENT

Minoxidil 5%
Biotin 0.2%

PURPOSE

Hair Regrowth

INDICATIONS & USAGE

Use to regrow hair of scalp and beard

WARNINGS

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

DO NOT USE

You have no family history of hair loss.
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 eyes. In case of accidental contact, rinse eyes with alarge amount of cool tap water.
You need to use this product 1 times a day for at least 3 months beforeyou see results, The amount of hair regrowth is different for each person.

STOP USE

Ifscalp irritation or redness occurs.
lf you get unwanted facial hair growth.
lf you do not see hair regrowth in 4 months.
lf sudden, unexplained weight gain occurs.

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 1 ml of Minoxidil Serum directly onto the scalp in the hair loss area.
Use fingertips to massage solution into skin/hair for 1 minutes thenwashhands thoroughly.
Men: use twice daily.Women: use once daily on clean, dry hair for best results.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

CASTOR OIL
ALCOHOL
GLYCERIN
CETYL ALCOHOL
LACTIC ACID
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL HAIR REGROWTH SOLUTION WITH BIOTIN 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83767-301
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	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
LACTIC ACID (UNII: 33X04XA5AT)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83767-301-01	1 in 1 PACKAGE	07/26/2024
1		60 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 83767-301-02	2 in 1 PACKAGE	07/26/2024
2		60 g in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 83767-301-03	3 in 1 PACKAGE	07/26/2024
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	M032	07/26/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Ruijiu Electronic Technology Co., Ltd.		631973699	manufacture(83767-301)