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Pantene Pro-V Expert Collection

Procter & Gamble Manufacturing Co.

Pantene Pro-V Expert Collection Hair Regrowth Treatment for Women


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

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. (1-800-222-1222)

Directions

  • apply one mL with dropper 2 times a day directly onto 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

Pantene Pro-V Expert Collection 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.
  • in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% 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 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive ingredients

alcohol, propylene glycol, purified water

Questions or comments?

call toll-free: 1-800-719-9260

Dist. by PROCTER & GAMBLE
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

CLINICALLY
PROVEN TO HELP
REGROW HAIR

PANTENE
PRO-V
EXPERT

COLLECTION

Minoxidil
TOPICAL SOLUTION USP, 2%

Hair Regrowth
Treatment for
Women

Unscented
Revitalizes Hair Follicles

1 MONTH SUPPLY

1-60 mL (2 FL OZ) bottle

APPROVED
FDA

Pantene Pro-V Expert Collection

Pantene Pro-V Expert Collection

Minoxidil LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37000-798
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, DROPPER
2 NDC:37000-798-60 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075357 2013-11-15


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