FDA Label for Mens Minoxidil Hair Regrowth
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
- PRINCIPAL DISPLAY PANEL - KIT CARTON
- PRINCIPAL DISPLAY PANEL - 2-60 ML BOTTLE DROPCARD
- PRINCIPAL DISPLAY PANEL - 200 ML BOTTLE LABEL-SHAMPOO
- PRINCIPAL DISPLAY PANEL - 200 ML BOTTLE LABEL-CONDITIONER
Mens Minoxidil Hair Regrowth Product Label
The following document was submitted to the FDA by the labeler of this product Topiderm, 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
Flammable: Keep away from fire or flame
Active Ingredient
Minoxidil 5% w/v
Purpose
Hair regrowth treatment for men
Use
to regrow hair on the scalp (vertex only, see picture on side of 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 the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution 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, 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.
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 opposite side
- before use, read all information on carton and enclosed leaflet
- keep the insert. It contains important information.
- hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
- in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
- store at controlled room temperature 20° to 25°C (68° to 77°F).
Inactive Ingredients
Alcohol, Propylene Glycol, Purified Water
Principal Display Panel - Kit Carton
MINOXIDIL
HAIR REGROWTH SYSTEM
CLINICALLY PROVEN TO HELP REGROW HAIR
KIT CONTENTS: STRENGTHENING SHAMPOO, REJUVENATING CONDITIONER,
MINOXIDIL TOPICAL SOLUTION USP (2 MONTH SUPPLY)
Principal Display Panel - 2-60 Ml Bottle Dropcard
MEN'S
MINOXIDIL
HAIR REGROWTH SYSTEM
5% MINOXODIL TOPICAL SOLUTION, USP
Reactivates hair follicles to
stimulate regrowth
Clinically proven to help regrow hair
Topical Solution
Unscented
Minoxidil Topical Solution 5% is for men who have
a general thinning of hair on the top of the scalp
(vertex only, as shown). Not intended for frontal baldness
or a receding hairline. Minoxidil Topical Solution 5%
has been shown to regrow hair in men with the following
degrees of thinning hair of hair loss
If men have more hair loss or hair loss in a place
different than shown above, Minoxidil Topical
Solution 5% may not work.
Two month supply
Two 60 ml (2 fl oz) bottles
Principal Display Panel - 200 Ml Bottle Label-Shampoo
COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC
Strengthening
Basil Root
Shampoo
HAIR GROWTH SYSTEM
Clean | Volumize | Strengthen
Net 6.7 fl. oz. (200 ml)
Available
Custom Branded
800.445.2595
[email protected]
Principal Display Panel - 200 Ml Bottle Label-Conditioner
COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC
Rejuvenating
Basil Root
Conditioner
HAIR GROWTH SYSTEM
Condition | Volumize | Rejuvenate
Net 6.7 fl. oz. (200 ml)
Available
Custom Branded
800.445.2595
[email protected]
* Please review the disclaimer below.