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Mens rogaine Unscented Formula

Dosage form: aerosol, foam
Ingredients: Minoxidil 50mg in 1g
Labeler: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.
NDC Code: 42002-106

Men's Rogaine 5% Minoxidil Topical Foam Unscented

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.

Directions
  • apply half a capful 2 times a day to the scalp in the hair loss area
  • massage into scalp with fingers, then wash hands well
  • see enclosed booklet for complete directions on how to use
  • 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
  • hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
  • see hair loss pictures on right
  • before use, read all information on package and enclosed booklet
  • keep the package. It contains important information.
  • store at controlled room temperature 20° to 25° C (68° to 77° F)
  • contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120° F (49° C).

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 800-ROGAINE or 215-273-8755 (collect)
  • visit www. rogaine.com

PRINCIPAL DISPLAY PANEL - 60 g Can Carton

NEW
LOOK
#1 DERMATOLOGIST RECOMMENDED BRAND

MEN'S
Rogaine®

5% MINOXIDIL TOPICAL AEROSOL
HAIR REGROWTH TREATMENT

REVITALIZES
HAIR FOLLICLES
EASY-TO-USE
FOAM

CLINICALLY PROVEN TO HELP REGROW HAIR

UNSCENTED
Not For Use By Women

Three Month Supply – Three 60 g (2.11 oz) Cans

MENS ROGAINE   UNSCENTED FORMULA
minoxidil aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-106
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Minoxidil (Minoxidil) Minoxidil50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butane 
Butylated Hydroxytoluene 
Cetyl Alcohol 
Citric Acid Monohydrate 
Glycerin 
Isobutane 
Lactic Acid 
Polysorbate 60 
Propane 
Water 
Stearyl Alcohol 
Packaging
#Item CodePackage Description
1NDC:42002-106-111 CAN in 1 PACKAGE
160 g in 1 CAN
2NDC:42002-106-133 CAN in 1 PACKAGE
260 g in 1 CAN
3NDC:42002-106-144 CAN in 1 PACKAGE
360 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02181210/01/2010
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 08/2012
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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