WOMEN'S alopexy 2% - 3 month supply

Drug Labeling and Warnings

Drug Details [pdf]

WOMENS ALOPEXY- minoxidil solution 
Genesis Pharmaceutical, Inc.

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WOMEN'S alopexy 2% - 3 month supply

Drug Facts

Active Ingredient

Minoxidil USP 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, 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.

Directions

  • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
  • apply 1 ml with sprayer (6 sprays) 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 with mostly white women age 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 women’s minoxidil topical solution 2% for 8 months; (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting 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 or Comments?

Call your health professional or Pierre Fabre at 1-800-459-8663. Monday – Friday: 9:00 AM – 5:00 PM (EST)

PRINCIPAL DISPLAY PANEL - Three - 60 mL Bottles Carton

NDC: 64760-601-03

DUCRAY

LABORATOIRES DERMATOLOGIQUES

WOMEN’S

alopexy

minoxidil topical solution USP, 2 %

hair regrowth treatment

Reactivates Hair Follicles To Stimulate Regrowth

Clinically Proven To Help Regrow Hair

Topical Solution

Unscented

Three Month Supply

Three - 60 mL (2 FL. OZ.) Bottles

WOMEN'S alopexy 2% - 3 month supply cartonWOMEN'S alopexy 2% - 3 month supply carton

WOMENS ALOPEXY 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64760-601
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: 64760-601-033 in 1 CARTON08/08/2016
1NDC: 64760-601-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07817608/08/201609/11/2019
Labeler - Genesis Pharmaceutical, Inc. (117196928)
Registrant - Genesis Pharmaceutical, Inc. (117196928)

Revised: 12/2018