ZOTOS PROFESSIONAL NUTRI FOR WOMEN 2% MINOXIDIL TOPICAL SOLUTION- minoxidil solution

ZOTOS PROFESSIONAL Nutri for Women 2% Minoxidil Topical Solution by

Drug Labeling and Warnings

ZOTOS PROFESSIONAL Nutri for Women 2% Minoxidil Topical Solution by is a Otc medication manufactured, distributed, or labeled by HENKEL US OPERATIONS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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, 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 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

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

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 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 the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
Store at controlled room temperature 20º to 25ºC (68º to 77ºF)

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

Questions?

Call toll-free 1-800-242-9283 Visit Website at zotosprofessional.com

Package Labeling:

INGREDIENTS AND APPEARANCE

ZOTOS PROFESSIONAL NUTRI FOR WOMEN 2% MINOXIDIL TOPICAL SOLUTION 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50663-395
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	20 mg  in 1 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: 50663-395-00	1 in 1 BOX	03/06/2023
1		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	ANDA078176	03/06/2023

Labeler - HENKEL US OPERATIONS CORPORATION (966706145)