5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN- minoxidil solution

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 Shenzhen Ctrip 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 0.2%

PURPOSE

Hair Regrowth

INDICATIONS & USAGE

Use to regrow hair of the scalp and beard growth for men

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 a large amount of cool tap water.

STOP USE

Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs.
Scalp irritation or redness occurs.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away.

KEEP OUT OF REACH OF CHILDREN

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

Apply 3-6 drops Minoxidil Serum directly onto scalp on the hair loss area
Use fingertips to massage solution into skin/hair for 1 minutes then washhands thoroughly.
Used once daily on clean dry hair for best results

STORAGE AND HANDLING

Before use, read all information on carton and enclosed leafletStore at controlled room temperature 10° to 30°C (50° to 80°F)Do not incinerate container. Do not expose toheat or store at temperature above 104°F(40°C)

INACTIVE INGREDIENT

Butylene Glycol
Glycerin
Alcohol
Panthenol
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84614-001
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 mL
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84614-001-01	2 in 1 PACKAGE	08/02/2024
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 84614-001-02	4 in 1 PACKAGE	08/02/2024
2		60 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	M032	08/02/2024

Labeler - Shenzhen Ctrip Technology Co., Ltd. (403113060)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Ctrip Technology Co., Ltd.		403113060	manufacture(84614-001)