5% MINOXIDIL WITH BIOTIN- minoxidil solution

5% Minoxidil with Biotin by

Drug Labeling and Warnings

5% Minoxidil with Biotin by is a Otc medication manufactured, distributed, or labeled by Guangzhou Borderless Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
lf 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.
lf 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 lossarea.
Use fingertips to massage solution into skin/hair for 1 minutes thenwash hands thoroughlye.
Used once daily on clean dry hair for best results.

INACTIVE INGREDIENT

Butylene Glycol
Glycerin
Alcohol
Panthenol
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL WITH BIOTIN 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85304-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	0.2 g  in 100 mL
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85304-001-02	2 in 1 BOX	03/11/2025
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 85304-001-04	4 in 1 BOX	03/11/2025
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 85304-001-06	6 in 1 BOX	03/11/2025
3		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	505G(a)(3)	03/11/2025

Labeler - Guangzhou Borderless Technology Co., Ltd. (452282332)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Borderless Technology Co., Ltd.		452282332	manufacture(85304-001)