Mens rogaine description, usages, side effects, indications, overdosage, supplying and lots more!

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Mens rogaine

Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

Men's Rogaine 5% Minoxidil Topical Foam Unscented


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Mens rogaine 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

Mens rogaine

Minoxidil AEROSOL, FOAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42002-106
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
minoxidil MINOXIDIL 50 mg

Inactive Ingredients

Ingredient Name Strength
BUTANE
BUTYLATED HYDROXYTOLUENE
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERIN
isobutane
LACTIC ACID
POLYSORBATE 60
propane
water
stearyl alcohol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 CAN
2 60 in 1 CAN
3 60 in 1 CAN
4 NDC:42002-106-14 4 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021812 2010-10-01


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