f7d77d71-566f-4b9f-90a7-7a4ae82f567f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T11:55:51.571738 · Updated: 2026-03-14T22:53:53.333843