MINOXIDIL- minoxidil aerosol, foam 
P & L Development, 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 men

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

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

Do not use if

  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Aerosol 5% (Foam) is not intended for frontal baldness or receding hairline.
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • 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. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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 men.

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 (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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

Compare to active ingredient in Men's Rogaine®

Men's

Hair Regrowth Treatment

Minoxidil Topical Aerosol, 5%

EASY-TO-USE FOAM

Not For Use By Women

1 CAN

60 g (2.11OZ CAN

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


Package label

Minoxidil 5% w/w (without propellant)

Men's Hair Regrowth Treatment

MINOXIDIL 
minoxidil aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-115
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:59726-115-6060 g in 1 CAN; Type 0: Not a Combination Product05/05/2023
2NDC:59726-115-703 in 1 PACKAGE05/05/2023
260 g in 1 CAN; Type 0: Not a Combination Product
3NDC:59726-115-652 in 1 PACKAGE05/05/2023
360 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20809205/05/2023
Labeler - P & L Development, LLC (800014821)

Revised: 5/2023
Document Id: 37efd9ba-3937-4d45-ba81-9112c37f07ec
Set id: 73dc7e7f-92c2-4ab2-a260-ceb198e591cf
Version: 3
Effective Time: 20230505
 
P & L Development, LLC