MINOXIDIL FOR WOMEN- minoxidil aerosol, foam

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1)
Available from:
Taro Pharmaceuticals U.S.A., Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Hair regrowth treatment for women to regrow hair on the top of the scalp (see pictures on side of this carton)
Authorization status:
Abbreviated New Drug Application
Authorization number:
51672-2129-4, 51672-2129-8

MINOXIDIL FOR WOMEN- minoxidil aerosol, foam

Taro Pharmaceuticals U.S.A., Inc.

----------

Minoxidil Topical Aerosol, 5% (For Women)

Drug Facts

Active ingredient

Minoxidil 5% w/w (without propellant)

Purpos e

Hair regrowth treatment for women

Us e

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. (1-800-222-1222)

Directions

see enclosed leaflet 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 leaflet

keep the carton. 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

butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic

acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

Ques tions ?

Call 1-866-923-4914

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 60 g Can Package

*Compare to the active

ingredient of

Women's Rogaine

NDC 51672-2129-4

Minoxidil

Topical Aerosol,

(For Women)

HAIR REGROWTH

TREATMENT

REACTIVATES

HAIR FOLLICLES

TO STIMULATE

REGROWTH

CLINICALLY

PROVEN TO

REGROW

HAIR

Once-a-Day

Foam

for Women

UNSCENTED

#1 DERMATOLOGIST

RECOMMENDED

ACTIVE INGREDIENT

Two Month

Supply

One 60 g

(2.11 oz) Can

MINOXIDIL FOR WOMEN

minoxidil aerosol, foam

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:516 72-2129

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Mino xidil (UNII: 59 6 5120 SH1) (Mino xidil - UNII:59 6 5120 SH1)

Mino xidil

50 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

butyla ted hydro xyto luene (UNII: 1P9 D0 Z171K)

cetyl a lco ho l (UNII: 9 36 JST6 JCN)

a nhydro us citric a cid (UNII: XF417D3PSL)

a lco ho l (UNII: 3K9 9 58 V9 0 M)

iso buta ne (UNII: BXR49 TP6 11)

la ctic a cid, unspecified fo rm (UNII: 33X0 4XA5AT)

buta ne (UNII: 6 LV4FOR43R)

po lyso rba te 6 0 (UNII: CAL22UVI4M)

pro pa ne (UNII: T75W9 9 11L6 )

wa ter (UNII: 0 59 QF0 KO0 R)

stea ryl a lco ho l (UNII: 2KR8 9 I4H1Y)

Product Characteristics

Color

WHITE (white to o ff-white fo am)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:516 72-2129 -4

1 in 1 PACKAGE

0 4/22/20 19

1

6 0 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

Taro Pharmaceuticals U.S.A., Inc.

2

NDC:516 72-2129 -8

2 in 1 PACKAGE

0 4/22/20 19

2

6 0 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 0 74

0 4/22/20 19

Labeler -

T aro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Taro Pharmaceutical Industries Ltd.

6 0 0 0 720 78

MANUFACTURE(516 72-2129 )

Revised: 1/2020

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