MENS ROGAINE MINOXIDIL - UNSCENTED FORMULA- minoxidil aerosol, foam

Mens rogaine Minoxidil by

Drug Labeling and Warnings

Mens rogaine Minoxidil by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 side of this carton
• 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 alcohol40-B, stearyl alcohol

Questions?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Three 60 g Can Package

#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

INGREDIENTS AND APPEARANCE

MENS ROGAINE MINOXIDIL   - UNSCENTED FORMULA
minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1)	Minoxidil	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Butane (UNII: 6LV4FOR43R)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Cetyl Alcohol (UNII: 936JST6JCN)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Isobutane (UNII: BXR49TP611)
Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)
Polysorbate 60 (UNII: CAL22UVI4M)
Propane (UNII: T75W9911L6)
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Stearyl Alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0031-1	1 in 1 PACKAGE	10/01/2010
1		60 g in 1 CAN; Type 0: Not a Combination Product
2	NDC: 69968-0031-3	3 in 1 PACKAGE	10/01/2010
2		60 g in 1 CAN; Type 0: Not a Combination Product
3	NDC: 69968-0031-4	4 in 1 PACKAGE	10/01/2010
3		60 g in 1 CAN; Type 0: Not a Combination Product

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

Labeler - Johnson & Johnson Consumer Inc. (002347102)