FDA Label for Minoxidil Topical Solution 2%
View Indications, Usage & Precautions
Minoxidil Topical Solution 2% Product Label
The following document was submitted to the FDA by the labeler of this product Sun Pharmaceutical Industries, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Minoxidil USP 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
- 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.
- 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
Ask a doctor before use if you have heart disease
When using this product
This product will not work for everyone
Stop use and ask a doctor if
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 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 leaflet
- keep the carton. It contains important information.
- In clinical studies of mostly white women aged 18 to 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 (59.85% v/v), propylene glycol, purified water
Questions?
Call toll-free 1-866-923-4914
Package/Label Principal Display Panel
NDC 51672-2152-4
Women’s Minoxidil Topical Solution USP, 2%
HAIR REGROWTH TREATMENT
REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH
CLINICALLY PROVEN TO HELP REGROW HAIR
UNSCENTED
One Month Supply
One 60 mL (2 fl oz) Bottle
* Please review the disclaimer below.
