5% MINOXIDIL HAIR REGROWTH SPRAYS WITH BIOTIN- minoxidil spray

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

5% Minoxidil Hair Regrowth SPRAY With Biotin

ACTIVE INGREDIENT

Minoxidil 5%
Biotin 0.5%

PURPOSE

Hair regrowth treatment

INDICATIONS & USAGE

use to regrow hair of scalp and beard

WARNINGS

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

DO NOT USE

You are a worran.
You have no family history of hair loss.
Your hair loss is sudden andjor patchy.
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

Do not apply on other parts of the body.
Avoid contact with eyes, In case of accidental contact, rinse eyes with a larpe amount of cool tap water.
The amount of hair regrowth is different for each person.This product wilt hot work for all men.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

if swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right avray.

DOSAGE & ADMINISTRATION

Apply 3-4 pumps of Extra Strength 5% Minoxidil Spray directly onto scalp on the hair loss area.
Use fingertips to massage the spray into skin/hair for 1 minute, then wash hands thoroughly.
Used twice 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° to 25°c (50° to 77°F).
Do not incinerate container, o not expose to heat or store at temperature above 104"F (40"C)

INACTIVE INGREDIENT

Castor oil
Alcohol
Glycerin
Butylene glycol
Panthenol
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL HAIR REGROWTH SPRAYS WITH BIOTIN 
minoxidil spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83767-601
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
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CASTOR OIL (UNII: D5340Y2I9G)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83767-601-01	1 in 1 PACKAGE	09/03/2024
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 83767-601-02	2 in 1 PACKAGE	09/03/2024
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 83767-601-03	3 in 1 PACKAGE	09/03/2024
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)	09/03/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Ruijiu Electronic Technology Co., Ltd.		631973699	manufacture(83767-601)