WOMENS ROGAINE UNSCENTED- minoxidil aerosol, foam

Womens Rogaine Unscented by

Drug Labeling and Warnings

Womens Rogaine Unscented 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 women

Use

to regrow hair on the top of the scalp (see pictures on side of this carton)

Warnings

For external use only.

Extremely Flammable

Avoid fire, flame, or smoking during and immediately following application.

Do not use if

• your degree of hair loss is different than that shown on side of this carton because this product may not work for you
• you have no family history of hair loss
• your hair loss is sudden and/or patchy
• your hair loss is associated with childbirth
• 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 use more than directed
• 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 3 months with once daily use. For some women, you may need to use this product once a day for at least 6 months before you see results.
• the amount of hair regrowth is different for each person. This product will not work for all women.

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 6 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

• see enclosed booklet for complete directions on how to use
• apply half a capful once daily directly to the scalp in the hair loss area
• massage into scalp with fingers, then wash hands well
• 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.
• store at controlled room temperature 20º to 25º C (68º to 77º 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)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 60 g Can Carton

#1 DERMATOLOGIST
RECOMMENDED BRAND

WOMEN'S
Rogaine®

5% Minoxidil
Topical Aerosol

Hair Regrowth
Treatment

REACTIVATES
HAIR FOLLICLES
TO STIMULATE
REGROWTH
CLINICALLY PROVEN
TO REGROW HAIR

Once-a-Day
Foam For Women

UNSCENTED

Four Month Supply
Two 60 g (2.11 oz) Cans

INGREDIENTS AND APPEARANCE

WOMENS ROGAINE UNSCENTED 
minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0030
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: 69968-0030-1	1 in 1 CARTON	04/01/2011
1		60 g in 1 CAN; Type 0: Not a Combination Product
2	NDC: 69968-0030-2	2 in 1 CARTON	04/01/2011
2		60 g in 1 CAN; Type 0: Not a Combination Product
3	NDC: 69968-0030-3	3 in 1 CARTON	04/01/2011
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	04/01/2011

Labeler - Johnson & Johnson Consumer Inc. (002347102)