NDC | 71713-095-10 |
Set ID | 5edbb188-5df6-8b87-e053-2991aa0a34f7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Thirty Madison Inc |
Generic Name | |
Product Class | Arteriolar Vasodilator |
Product Number | |
Application Number | ANDA074588 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
For external use only. For use by men only.
Flammable: Keep away from fire or flame
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
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
May be harmful if used when pregnant or breast-feeding. - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
OTHER SAFETY 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.
• 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 20º to 25ºC (68º to 77ºF). - INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KEEPS
minoxidil 5% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71713-095 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71713-095-10 3 in 1 BOX 11/15/2017 1 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074588 11/15/2017 Labeler - Thirty Madison Inc (080774087)