MINOXIDIL- minoxidil aerosol, foam 
Profectus Beauty, LLC

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Minoxidil Topical Solution for Men

Drug Facts

Active ingredient

Minoxidil 5% w/w (without propellant)

Purpose

Hair regrowth treatment for women

Use

to regrow hair on the top of the scalp (see pictures on side of this carton)

Warnings

For external use only.
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

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 use more than directed
  • 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 3 months with once daily use For some women, you may need to use this product once a day for at least 6 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 6 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40-B, stearyl alcohol

Questions?

Call toll free 1-888-237-4131

Principal display panel

*Compare to active ingredient in Women's Rogaine®

Minoxidil

Topical Aerosol, 5%

Hair Regrowth Treatment For Women

Clinically proven to help regrow hair

Reactivates hair follicles to stimulate regrowth

Unscented

Once-a Day

Foam for women

TWO MONTH SUPPLY

60 g (2.11OZ CAN

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Women's Rogaine®.

Distributed by:

Profectus Beauty, LLC.,

111 Town Square Pl, Suite 1130

Jersey City, NJ 07310

Package label

Minoxidil 5% w/w (without propellant)

KERANIQUE Hair Regrowth Treatment For Women

MINOXIDIL 
minoxidil aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70550-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTANE (UNII: 6LV4FOR43R)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOBUTANE (UNII: BXR49TP611)  
LACTIC ACID (UNII: 33X04XA5AT)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPANE (UNII: T75W9911L6)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70550-116-021 in 1 PACKAGE03/15/2024
160 g in 1 CAN; Type 0: Not a Combination Product
2NDC:70550-116-202 in 1 PACKAGE03/15/2024
260 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20809203/15/2024
Labeler - Profectus Beauty, LLC (118310694)

Revised: 3/2024
Document Id: deeb4d9b-55c3-4fc3-b9c9-c8e06f5212d0
Set id: 4af782f4-68d5-4338-a0a6-85d11a23ce98
Version: 5
Effective Time: 20240314
 
Profectus Beauty, LLC