GAINEXTRA HAIR REGROWTH TREATMENT FOR MEN 5%- minoxidil 5% spray

Gainextra Hair Regrowth Treatment for Men 5% by

Drug Labeling and Warnings

Gainextra Hair Regrowth Treatment for Men 5% 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

Minoxidil 5% w/v

PURPOSE

Hair regrowth treatment for men

USE

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

WARNINGS

For external use only

Flammable: Keep away from fire or flame

DO NOT USE

Do not use if

■ you are a woman

■ your amount of hair loss is dierent than that shown on the side of this carton, or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness 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 everyone.

STOP USE

■ 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.

DIRECTIONS

■ Prim the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.

■ apply one mL (6 sprays) 2 times a day directly onto the scalp in the area of hair loss

■ 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

■ see hair loss pictures on side of this carton

■ before use, read all information on carton and enclosed leaflet

■ keep this carton. It contains important information.

■ hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men

■ in clinical studies of mostly white men aged 18-19 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

■ store at controlled room temperature between 68°-77°F (20°-25°C).

INACTIVE INGREDIENT

alcohol, propylene glycol, purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GAINEXTRA HAIR REGROWTH TREATMENT FOR MEN 5% 
minoxidil 5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82429-261
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
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82429-261-10	1 in 1 BOX	10/23/2023
1		100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076239	10/23/2023

Labeler - Gabar Health Sciences Corp. (118401847)