MENS ROGAINE  EXTRA STRENGTH- minoxidil solution 
Johnson & Johnson Consumer Inc.

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Men's Rogaine Extra Strength 5%
Unscented Solution
Carton

Drug Facts

Active ingredient

Minoxidil 5% w/v

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.

Flammable: Keep away from fire or flame

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. 5% minoxidil topical solution 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.

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 booklet
  • keep the carton. It contains important information.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
  • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
  • store at controlled room temperature 20° to 25° C (68° to 77° F)

Inactive ingredients

alcohol, propylene glycol, purified water

Questions?

  • call us at 1-800-ROGAINE (1-800-764-2463)
  • visit rogaine.com

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

#1 DERMATOLOGIST
RECOMMENDED BRAND

NEW LOOK

MEN'S
Rogaine®
EXTRA STRENGTH

5% Minoxidil
Topical Solution
Hair Regrowth Treatment

REACTIVATES
HAIR FOLLICLES
TO STIMULATE REGROWTH

Topical Solution

CLINICALLY PROVEN TO
HELP REGROW HAIR
UNSCENTED
Not For Use By Women

One Month Supply * One 60 mL (2 fl oz) Bottle

Principal Display Panel - 60 mL Bottle Carton
MENS ROGAINE   EXTRA STRENGTH
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1) Minoxidil50 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:42002-101-021 in 1 CARTON07/16/201012/01/2018
160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:42002-101-063 in 1 CARTON07/16/201012/01/2018
260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083407/16/201012/01/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 12/2016
Document Id: a3d4f3d0-402d-48f2-9f2d-578dc79e0ba2
Set id: beb0eb05-1ffd-4b68-bc61-35805e2bebdd
Version: 4
Effective Time: 20161220
 
Johnson & Johnson Consumer Inc.