MINOXIDIL  5% (FOR MEN)- minoxidil aerosol, foam 
Thirty MADISON, Inc.

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Minoxidil
5% (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 this 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 side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical 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 right away. (1-800-222-1222)

Directions

Other information

Inactive ingredients

butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

Distributed by:
Thirty Madison, Inc. New York, NY 10016

PRINCIPAL DISPLAY PANEL - 60 g Can Carton

Keeps

Minoxidil Topical Aerosol, 5% (For Men)

HAIR REGROWTH TREATMENT

Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

#1 Dermatologist Recommended Active Ingredient

Easy-to-use foam unscented

THREE MONTH SUPPLY
THREE 60 g (2.11 OZ) CANS

NOT FOR USE BY WOMEN

PRINCIPAL DISPLAY PANEL - 60 g Can Carton
MINOXIDIL   5% (FOR MEN)
minoxidil aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71713-091
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
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
cetyl alcohol (UNII: 936JST6JCN)  
anhydrous citric acid (UNII: XF417D3PSL)  
ALCOHOL (UNII: 3K9958V90M)  
isobutane (UNII: BXR49TP611)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
BUTANE (UNII: 6LV4FOR43R)  
polysorbate 60 (UNII: CAL22UVI4M)  
propane (UNII: T75W9911L6)  
WATER (UNII: 059QF0KO0R)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Product Characteristics
ColorWHITE (white to off-white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71713-091-303 in 1 CARTON03/23/2022
160 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20907403/23/2022
Labeler - Thirty MADISON, Inc. (080774087)

Revised: 4/2022
Document Id: 19f93b56-e00a-42ee-8255-7d47f10fd273
Set id: 985ba944-147c-4207-b34b-ede702c3d704
Version: 1
Effective Time: 20220401
 
Thirty MADISON, Inc.