ZOTOS PROFESSIONAL NUTRI FOR WOMEN 2% MINOXIDIL TOPICAL SOLUTION- minoxidil solution 
HENKEL US OPERATIONS CORPORATION

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ZOTOS PROFESSIONAL Nutri for Women 2% Minoxidil Topical Solution

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:

Outer PackageInner Package

ZOTOS PROFESSIONAL NUTRI FOR WOMEN 2% MINOXIDIL TOPICAL SOLUTION 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50663-395
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50663-395-001 in 1 BOX03/06/2023
160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07817603/06/2023
Labeler - HENKEL US OPERATIONS CORPORATION (966706145)

Revised: 2/2023
Document Id: f5483598-9d8d-1d4e-e053-2a95a90a9054
Set id: ec3cfa5f-b408-47f0-a824-47ef5982e5e4
Version: 1
Effective Time: 20230222
 
HENKEL US OPERATIONS CORPORATION