FDA Label for Minoxidil
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- DO NOT USE IF
- OTC - ASK DOCTOR
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 60 ML BOTTLE CARTON
Minoxidil Product Label
The following document was submitted to the FDA by the labeler of this product H2-pharma, Llc. 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.
Other
Drug Facts
Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
Active Ingredient
Minoxidil, USP 2% w/v
Purpose
Hair regrowth treatment
Use
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
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
- 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
Otc - Ask Doctor
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
Otc - Pregnancy Or Breast Feeding
May be harmful if used when pregnant or breast-feeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 men aged 18 to 49 years with moderate degrees of hair loss, the following response to minoxidil topical solution 2% for men was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical solution 2% for men for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth).
- store at controlled room temperature 20° to 25°C (68° to 77°F)
Inactive Ingredients
alcohol (60% v/v), propylene glycol, purified water
Questions?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel - 60 Ml Bottle Carton
NDC 61269-066-75
*Compare to the active ingredient in
Men's Rogaine®
FOR MEN
Minoxidil
Topical Solution,
USP 2%
Hair regrowth treatment
Reactivates hair follicles to stimulate regrowth
Clinically proven to help regrow hair
Unscented
FOR BEST RESULTS
Apply directly to scalp twice daily
TWO MONTH SUPPLY
Two 60 mL (2 fl oz) bottles
H2 pharma
* Please review the disclaimer below.