FDA Label for Gainxtra Hair Regrowth Treatment For Men And Women Minoxidil 5% Form With Biotin

Other

DRUG FACTS

Active Ingredient

Minoxidil  5% w/w

(without propellant)

Purpose

Hair regrowth treatment for men and women

Use

To regrow hair the scalp

Warnings

For external use only.

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

Do Not Use If:

• the amount of hair loss is different the amount that is shown on the carton or your hair loss is on the front of the scalp. 5% Minoxidil Form is not intended for frontal baldness of receding hairline.
• you have no family history of hair loss
• your hair is sudden and/or patchy
• you do not know the reason for your hair loss
• you are 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

Otc - Ask Doctor

Ask a doctor before use if you have heart disease.

When Using This Product

• do not apply to other body parts
• 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. Some men and women may need to use this product for up to 4 months before seeing results
• the amount of hair regrowth is different for each person. This product will not work for all men and women

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 within 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. (1-800-222-1222)

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.
• using more or more often will not improve results.
• continued use is necessary to increase and maintain your hair regrowth or hair loss will begin again

Other Information

• hair growth has been shown in a clinical study of men and women aged 18-49 years who used it for 4 months
• read all information and the enclosed leaflet before use
• store at this controlled room temperature 20° to 25°C (68° to 77°F)
• do not expose to hear or store in temperatures above 120°F (49°C)
• increasing the dose or frequency of use will not accelerate hair growth

Inactive Ingredients

Purified water, Propylene Glycol, Hyaluronic Acid, Cocamidopropyl Betadine, Keratine, Amino Acids, Tocopherol (Vitamin E), Glycerin, Xanthan Gum, Capryloyl Silk Amino Acids, Allantoin, Aloe Barbadensis Leaf Extract, Citrus Paradisi (Grapefruit) Seed Extract, Polygonum Cuspidatum Extract, Biotin, Ethylhexylglycerin.

Questions?

Call(1-248-923-5024) or gainxtra.com

Manufactured for and distributed by:

Gainxtra LLC

3162 Martin Road

Commerce Township, MI 48390

Package Label.Principal Display Panel

1 - label

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