5% MINOXIDIL WITH BIOTIN TOPICAL SOLUTION- minoxidil solution

5% minoxidil with biotin topical solution by

Drug Labeling and Warnings

5% minoxidil with biotin topical solution 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 0.5%

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 eves. in case of accidental contact, rinse eves 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

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 loss area.
Use fingertips to massage solution into skin/hair for 1 minutes then wash hands thoroughly.
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 TOPICAL SOLUTION 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85304-021
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
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85304-021-01	6 in 1 PACKAGE	10/30/2025
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 85304-021-02	8 in 1 PACKAGE	10/30/2025
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	505G(a)(3)	10/30/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Borderless Technology Co., Ltd.		452282332	manufacture(85304-021)