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

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MEN'S Rogaine ® EXTRA STRENGTH UNSCENTED

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

Other information

Inactive ingredients

alcohol, propylene glycol, purified water

Questions?

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman,NJ 08558

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

#1 DERMATOLOGIST

RECOMMENDED BRAND

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

Rogaine_01

MENS ROGAINE EXTRA STRENGTH UNSCENTED 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0089
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:69968-0089-11 in 1 CARTON07/16/2010
160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:69968-0089-33 in 1 CARTON07/16/2010
260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083407/16/2010
Labeler - Johnson & Johnson Consumer Inc. (118772437)

Revised: 4/2023
Document Id: f9368225-dee1-1f9c-e053-6294a90a6d5b
Set id: ccaecec5-5348-4b24-9190-5464c50f6d80
Version: 4
Effective Time: 20230413
 
Johnson & Johnson Consumer Inc.