Gainextra-5% Minoxidil Topical Solution, USP

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]

GAINEXTRA HAIR REGROWTH TREATMENT FOR MEN 5%- minoxidil 5% spray 
Gabar Health Sciences Corp.

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Gainextra-5% Minoxidil Topical Solution, USP

Minoxidil 5% w/v

Hair regrowth treatment for men

USE

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

For external use only

Flammable: Keep away from fire or flame

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 a doctor before use if you have heart disease

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.

■ 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

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

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.

■ 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).

alcohol, propylene glycol, purified water

box

GAINEXTRA HAIR REGROWTH TREATMENT FOR MEN 5% 
minoxidil 5% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82429-261
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82429-261-101 in 1 BOX10/23/202308/12/2024
1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623910/23/202308/12/2024
Labeler - Gabar Health Sciences Corp. (118401847)

Revised: 8/2024