NIOXIN HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil solution

Nioxin Hair Regrowth Treatment for Women by

Drug Labeling and Warnings

Nioxin Hair Regrowth Treatment for Women by is a Otc medication manufactured, distributed, or labeled by The Wella Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on the scalp

Warnings

For external use only

Flammable: Keep away from fire or flame

Do not use if

• your degree 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, 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. You may need to use this product 2 times a day 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 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

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 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 side of this carton
• before use, read all information on carton and enclosed leaflet
• keep the carton. 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 minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
• store at 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive ingredients

alcohol, propylene glycol, purified water

Questions?

Call 1-800-719-9260

SPL UNCLASSIFIED SECTION

Dist. by THE WELLA CORPORATION,
WOODLAND HILLS, CA 91367

PRINCIPAL DISPLAY PANEL - 3 Bottle Carton

NIOXIN®

MINOXIDIL
TOPICAL SOLUTION USP 2%

HAIR REGROWTH
TREATMENT

FOR WOMEN

Clinically Proven To Help Regrow Hair
Reactivates Hair Follicles To Stimulate Regrowth

THREE MONTH SUPPLY
FDA APPROVED

3-60 mL (2 fl oz) Bottles
UNSCENTED

INGREDIENTS AND APPEARANCE

NIOXIN HAIR REGROWTH TREATMENT FOR WOMEN 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69282-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1)	Minoxidil	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69282-001-60	1 in 1 CARTON
1		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 69282-001-18	3 in 1 CARTON
2		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075357	11/01/2014

Labeler - The Wella Corporation (829413157)

Registrant - Procter & Gamble Manufacturing Co. (004238200)