Hair Regrowth Treatment for Women description, usages, side effects, indications, overdosage, supplying and lots more!

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Hair Regrowth Treatment for Women

Wal-Mart Stores, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

  • your degree of hair loss is more 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

  • 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.
  • 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.

  • part your hair and apply with dropper one mL 2 times a day directly onto the scalp in the area of hair thinning/loss
  • 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

Hair Regrowth Treatment for Women Other information

  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed booklet
  • keep this 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).  Keep tightly closed.

Inactive ingredients

alcohol, 60% v/v, propylene glycol, purified water

Call: 1-888-287-1915

This Package Contains

·         Three 60 mL (2 FL OZ) bottles of Minoxidil Topical Solution (three month supply)

·         One child-resistant dropper applicator

·         Information leaflet on how to use and obtain best results

Using the Dropper Applicator

1. Remove cap by pushing and turning in direction of the arrows on the cap

2. Squeeze the rubber bulb and insert the dropper into the bottle. Release the bulb, allowing the dropper to fill to the 1 mL line. If the level of the solution is above the 1 mL line, squeeze the extra amount back into the bottle.

3. Place the tip near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. To prevent the solution from running off the scalp, apply a small amount at a time.

4. After each use attach the dropper to the bottle to make it child-resistant by turning it clockwise until tightly closed.

00660109G2 VC110303 2005444

Distributed by:

Wal-Mart Stores, Inc.

Bentonville, AR 72716

©Wal-Mart Stores, Inc

Made in Canada

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Rogaine®.

Minoxidil Topical Solution is for women who have a general thinning of hair on the top of the scalp as shown. Minoxidil Topical Solution has been shown to regrow hair in women with the following degrees of thinning hair or hair loss.

Hair Regrowth Treatment for Women

If women have more hair loss than shown above, Minoxidil Topical Solution may not work.

Do not use if you have patchy hair loss as shown below.

Hair Regrowth Treatment for Women

Satisfaction guaranteed – Or we’ll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

PRINCIPAL DISPLAY PANEL

equate®
Compare to Rogaine® for Women Active Ingredient*

Hair Regrowth
Treatment
For Women

Minoxidil Topical Solution USP 2%

Helps Regrow Hair

  • Revitalizes hair follicles

3 Month Supply

3-2 FL OZ (60 mL) BOTTLES

Hair Regrowth Treatment for Women

Hair Regrowth Treatment for Women

Minoxidil SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49035-006
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
minoxidil MINOXIDIL 20 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
propylene glycol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE, PLASTIC
2 NDC:49035-006-76 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074588 2004-02-04


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