SPL v1
SPL
SPL Set ID f7d77d71-566f-4b9f-90a7-7a4ae82f567f
Route
TOPICAL
Published
Effective Date 2014-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (2 g)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2014-04-01

Description

Minoxidil, USP 2% w/v

Purpose

Hair regrowth treatment


Medication Information

Indications and Usage

Use to regrow hair on the scalp

Purpose

Hair regrowth treatment

Description

Minoxidil, USP 2% w/v

Section 50565-1

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.

Section 50566-9

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
Section 50567-7

When using this product

  • do not apply on other parts of the body
  • avoid contact with the eyes. In case of accidental contact, rinse 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.
Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1

Do not use if

  • your degree of hair loss is more than that shown on the side of this carton, because this propuct 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
Section 51727-6

Inactive ingredients alcohol (60% v/v), propylene glycol, purified water

Section 53413-1

Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Warnings

For external use only

Flammable: Keep away from fire or flame

Directions
  • 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
Drug Facts

Active Ingredient

Minoxidil, USP 2% w/v

Other Information
  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed leaflet
  • 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 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 controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.
———package Label.principal Display Panel———

NDC 60900-555-30

Compare to the active ingredient

in Women's Rogaine®*

EMPRESS®

Re-Gro™ Hair Products for Women of Color

Hair Regrowth

Treatment

Minoxidil Topical

Solution,

USP 2%

FOR WOMEN

Unscented

Clinically Proven to

Help Regrow Hair

Revitalized Hair Follicles

Three Month Supply

3-60 mL (2 fl oz) Bottles


Structured Label Content

Indications and Usage (34067-9)

Use to regrow hair on the scalp

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product

  • do not apply on other parts of the body
  • avoid contact with the eyes. In case of accidental contact, rinse 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.
Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)

Do not use if

  • your degree of hair loss is more than that shown on the side of this carton, because this propuct 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
Section 51727-6 (51727-6)

Inactive ingredients alcohol (60% v/v), propylene glycol, purified water

Section 53413-1 (53413-1)

Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Purpose

Hair regrowth treatment

Warnings

For external use only

Flammable: Keep away from fire or flame

Directions
  • 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
Drug Facts

Active Ingredient (Active ingredient)

Minoxidil, USP 2% w/v

Other Information (Other information)
  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed leaflet
  • 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 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 controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.
———package Label.principal Display Panel——— (———Package Label.Principal Display Panel———)

NDC 60900-555-30

Compare to the active ingredient

in Women's Rogaine®*

EMPRESS®

Re-Gro™ Hair Products for Women of Color

Hair Regrowth

Treatment

Minoxidil Topical

Solution,

USP 2%

FOR WOMEN

Unscented

Clinically Proven to

Help Regrow Hair

Revitalized Hair Follicles

Three Month Supply

3-60 mL (2 fl oz) Bottles


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)