Label: MINOXIDIL EXTRA STRENGTH FOR MEN- minoxidil solution
- NDC Code(s): 72484-095-03, 72484-095-06
- Packager: Roman Health Ventures Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 9, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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. Minoxidil topical solution 5% 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
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
- 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 minoxidil topical solution 5% for men
- In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
- store at controlled room temperature 20° to 25°C (68° to 77°F)
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
NOT FOR USE BY WOMEN:
May grow facial hair. May be harmful if used during pregnancy or breast-feeding.
For best results, apply directly to scalp twice daily.
Minoxidil Topical Solution USP 5% is for men who have a general thinning of the hair on the top of the scalp (vertex only as shown below). Not intended for frontal baldness or a receding hairline. Minoxidil Topical Solution 5% for men has been shown to regrow hair in men with the following degrees of thinning hair or hair loss.
- Single Bottle Package
- Three bottle package
INGREDIENTS AND APPEARANCE
MINOXIDIL EXTRA STRENGTH FOR MEN
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72484-095 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72484-095-03 1 in 1 CARTON 05/08/2020 1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:72484-095-06 3 in 1 CARTON 05/19/2021 2 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 05/08/2020 Labeler - Roman Health Ventures Inc. (081317350)