5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution

5% Minoxidil Topical Solution by

Drug Labeling and Warnings

5% Minoxidil Topical Solution by is a Otc medication manufactured, distributed, or labeled by Gabar Health Sciences Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Drug Facts

​Active Ingredient

Minoxidil 5% w/w (without propellant)

​Purpose

Hair regrowth treatment for men

​Use

To regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

​Warnings

For external use only.

For use by men only.

​ ​Extremely Flammable:​ Avoid fire, flame, or smoking during and immediately following application.

​Do not use if

• you are a woman
• your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp 5% minoxidil topical foam is not intended for frontal baldmess or receding hairline.
• you have no family history of hair loss
• your hair loss is sudden and/or 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

ASK DOCTOR

​Ask a doctor before use if you have heart disease

WHEN USING

​When using this product

• ​do not apply on other parts of the body
• avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
• some people have experienced changes in hair color and/or texture
• it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results
• the amount of hair regrowth is different for each person. This product will not work for all men.

STOP USE

​Stop use and ask a doctor if

• ​chest pain, rapid heartbeat, faintness, or dizziness occurs
• sudden, unexplained weight gain occurs
• your hands or feet swell
• scalp irritation or redness occurs
• unwanted facial hair growth occurs
• you do not see hair regrowth in 4 months

PREGNANCY OR BREAST FEEDING

​May be harmful if used when pregnant or breast feeding.

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION

​Directions

• ​apply half a capful 2 times a day to the scalp in the hair loss area
• massage into scalp with fingers, then wash hands well
• see enclosed leaflet for complete directons on how to use
• using more or more often will not improve results
• continued use is necessary to increase and keep your hair regrowth or hair loss will begin again

OTHER SAFETY INFORMATION

​Other information​

• hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
• see hair loss picture on side of this carton
• before use, read all information on carton and enclosed leaflet
• keep the carton. It contains important information.
• store at controlled room temperature 20º to 25ºC (68º to 77ºF)
• contents under pressure. Do not puncture or incinerate container.
• do not expose to heat or store at temperature above 120ºF (49ºC).

INACTIVE INGREDIENT

​Inactive ingredients

​butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

QUESTIONS

​Questions?

• ​Call ​1-470-737-9424

Manufactured and distributed by:

Gabar Health Sciences Corp., Atlanta, GA 30385

​PRINCIPAL DISPLAY PANEL

​Minoxidil Topical Aerosol, 5% (For Men)

HAIR REGROWTH TREATMENT

​Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

#1 Dermatologist Recommended Active Ingredient

Easy-to-use-foam unscented

3 MONTH SUPPLY

3 - 60 g (2.11 OZ) CANS

​NOT FOR USE BY WOMEN

INGREDIENTS AND APPEARANCE

5% MINOXIDIL TOPICAL SOLUTION 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82429-200
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

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ALCOHOL (UNII: 936JST6JCN)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
LACTIC ACID (UNII: 33X04XA5AT)
BUTANE (UNII: 6LV4FOR43R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPANE (UNII: T75W9911L6)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	white (white to off-white foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82429-200-60	60 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/10/2022

Labeler - Gabar Health Sciences Corp. (118401847)

Registrant - Gabar Health Sciences Corp. (118401847)

Establishment
Name	Address	ID/FEI	Business Operations
Gabar Health Sciences Corp.		118401847	manufacture(82429-200)