FDA Label for Minoxidil 5% (for Men)
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 G CAN PACKAGE
Minoxidil 5% (for Men) Product Label
The following document was submitted to the FDA by the labeler of this product Taro Pharmaceuticals U.s.a., 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.
Other
Drug Facts
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.
Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Active Ingredient
Minoxidil 5% w/w (without propellant)
Purpose
Hair regrowth treatment for men
Use
to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
Warnings
For external use only.
For use by men only.
Do Not Use If
- you are a woman
- your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline.
- 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. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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 all men.
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 right away. (1-800-222-1222)
Directions
- apply half a capful 2 times a day to the scalp in the hair loss area
- massage into scalp with fingers, then wash hands well
- see enclosed leaflet for complete directions on how to use
- 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
- hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
- 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.
- store at controlled room temperature 20° to 25°C (68° to 77°F)
- contents under pressure. Do not puncture or incinerate container.
- do not expose to heat or store at temperatures above 120°F (49°C).
Inactive Ingredients
butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol
Questions?
- Call 1-866-923-4914
Principal Display Panel - 60 G Can Package
*Compare to the active
ingredient of
Men's Rogaine®
NDC 51672-2128-4
Minoxidil
Topical Aerosol,
5% (For Men)
HAIR REGROWTH
TREATMENT
REACTIVATES
HAIR FOLLICLES
TO STIMULATE
REGROWTH
CLINICALLY
PROVEN TO HELP
REGROW HAIR
Easy-to-use
foam
UNSCENTED
#1 DERMATOLOGIST
RECOMMENDED
ACTIVE INGREDIENT†
Not For Use By Women
One Month Supply
One 60 g (2.11 oz) Can
* Please review the disclaimer below.