Label: GAINEXTRA HAIR REGROWTH TREATMENT FOR MEN 5%- minoxidil 5% spray
- NDC Code(s): 82429-261-10
- Packager: Gabar Health Sciences Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 21, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
-
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
-
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GAINEXTRA HAIR REGROWTH TREATMENT FOR MEN 5%
minoxidil 5% sprayProduct 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)