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Rogaine®
2014-02-16 12:48:35 来源: 作者: 【 】 浏览:776次 评论:0
Women's Rogaine 2%
Unscented Solution
Carton

 

 

Drug Facts

 

Active ingredient

Minoxidil 2% w/v

 

Purpose

Hair regrowth treatment

 

Use

to regrow hair on the scalp

 

Warnings

For external use only

Flammable: Keep away from fire or flame

 

Do not use if

  • your degree of hair loss is different than that shown on the 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 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. You may need to use this product 2 times a day 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 everyone.

 

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 one mL with dropper 2 times a day directly onto the scalp in the hair loss area
  • 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.
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • store at controlled room temperature 20° to 25° C (68° to 77° F)

 

Inactive ingredients

alcohol, propylene glycol, purified water

 

Questions?

  • call us at 1-800-ROGAINE (1-800-764-2463)
  • visit rogaine.com
  • for more information about hair thinning, visit womenhairinstitute.com

 

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

WOMEN'S
Rogaine®

2% MINOXIDIL
TOPICAL SOLUTION

HAIR REGROWTH
TREATMENT

UNSCENTED

CLINICALLY PROVEN
TO HELP REGROW HAIR

REACTIVATES HAIR FOLLICLES
TO STIMULATE REGROWTH

One Month Supply
1-60 mL (2 fl oz) Bottle

DERMATOLOGIST
#1
RECOMMENDED BRAND

Principal Display Panel - 60 mL Bottle Label

WOMENS ROGAINE  EXTRA STRENGTH
minoxidil   solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 42002-105
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Minoxidil (Minoxidil) Minoxidil 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Alcohol  
Propylene Glycol  
Water  
Product Characteristics
Color      Score     
Shape   Size  
Flavor   Imprint Code  
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 42002-105-02 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1   60 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (42002-105-02)
2 42002-105-06 3 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
2   60 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (42002-105-06)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019501 08/01/2010  

Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)
Revised: 05/2011Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.  
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