FDA Label for Womens Minoxidil Hair Regrowth

Other

Drug Facts

For external use only.

Flammable: Keep away from fire or flame

Active Ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on the scalp (vertex only, see picture on side of carton)

Do Not Use If

• your amount of hair loss is different than that shown on the side of this carton, because this product may not work for you
• you have no family history of hair loss
• your hair loss is sudden and/or patchy
• your hair loss is associated with childbirth
• 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, 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 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 women, 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 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 in 4 months

Otc - Pregnancy Or Breast Feeding

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

Otc - 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

• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
• 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 Information

• see hair loss pictures on opposite side
• before use, read all information on carton and enclosed leaflet
• keep the insert. It contains important information.
• In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
• store at USP controlled room temperature 20° to 25°C (68° to 77°F)

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Principal Display Panel - Kit Carton

MINOXIDIL
HAIR REGROWTH SYSTEM

CLINICALLY PROVEN TO HELP REGROW HAIR

KIT CONTENTS: STRENGTHENING SHAMPOO, REJUVENATING CONDITIONER,
MINOXIDIL TOPICAL SOLUTION USP (2 MONTH SUPPLY)

Principal Display Panel - Kit Carton - minoxidil 01

Principal Display Panel - 2-60 Ml Bottle Dropcard

WOMEN'S
MINOXIDIL
HAIR REGROWTH SYSTEM

2% MINOXODIL TOPICAL SOLUTION, USP

Reactivates hair follicles to
stimulate regrowth

Clinically proven to help regrow hair

Topical Solution

Unscented

Minoxidil Topical Solution 2% is for women who have
a general thinning of hair on the top of the scalp
(vertex only, as shown below). Minoxidil Topical Solution
2% has been shown to regrow hair in women with the
following degrees of thinning hair of hair loss

If women have more hair loss than shown above,
Minoxidil Topi cal Solution 2% may not work.

Do not use if you have patchy hair loss as shown above.

Two month supply
Two 60 ml (2 fl oz) bottles

Principal Display Panel - 2-60 mL Bottle Dropcard - minoxidil 02

Principal Display Panel - 200 Ml Bottle Label-Shampoo

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

Strengthening
Basil Root
Shampoo

HAIR GROWTH SYSTEM

Clean | Volumize | Strengthen

Net 6.7 fl. oz. (200 ml)

Available
Custom Branded
800.445.2595
[email protected]

Principal Display Panel - 200 mL Bottle Label-Shampoo - minoxidil 03

Principal Display Panel - 200 Ml Bottle Label-Conditioner

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

Rejuvenating
Basil Root
Conditioner

HAIR GROWTH SYSTEM

Condition | Volumize | Rejuvenate

Net 6.7 fl. oz. (200 ml)

Available
Custom Branded
800.445.2595
[email protected]

Principal Display Panel - 200 mL Bottle Label-Conditioner - minoxidil 04