Label: MINOXIDIL EXTRA STRENGTH FOR MEN- minoxidil spray
- NDC Code(s): 72484-097-01, 72484-097-02
- Packager: Roman Health Ventures Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
Prime the sprayer by holding the bottle the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist
Apply one mL with spray (6 sprays) 2 times a day directly onto the scalp in the hair loss area
Using more or more often will not improve restuls
Continued use is necessary to increase and keep your hair regrowth, or hair loss will begind again.
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OTHER SAFETY INFORMATION
Other information
See hair loss pictures on side of this carton
Before use, read all information on carton and enclosed leaflet
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
Keep the carton. It contains important information.
In clinical studies of mostly white men aged 18-45 years with moderate degrees of hairloss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
Store at controlled room temperature 20 to 25C (68 to 77F)
- INACTIVE INGREDIENT
- QUESTIONS
- 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
Minoxidil 5% Topical Solution, USP
Minoxidil 5% Topical Solution
is for men who have a general
thinning of hair on the top of
the scalp vertex only, as
shown below. Not intended
for frontabl baldness or a
receding hairline. Minoxidil
Topical Solution 5% has been
shown to regrow hair in men
with the following degrees of
thinning hair or hairloss.
If men have more hair loss or hair loss in
a place different than showing above, Minoxidil
Topical Solution 5% for men may not work.
For best results:
Apply direclty to scalp. Use twice daily.
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Three Bottle Package
NDC xxxxx-xxx-xx
roman
HAIR
REGROWTH
TREATMENT
5% Minoxidil Topical Solution, USP
Extra Strength formula for men
Clinically proven to help regrow hair
Reactivates hair follicles to stimulate growth
Easy precision sprayer
Unscented topical solution
Three month supply
3- 60 mL (2 fl oz) bottles
Total 180 mL (6 fl oz)
Not for use by women
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Single Bottle Package
NDC XXXXX-XXX-XX
roman
Hair Regrowth Treatment
5% Minoxidil Topical Solution, USP
Extra Strength formula for men
Clinically proven to help regrow hair
Reactivates hair follicales to stimulate regrowth
Easy precision sprayer
Unscented topical solution
One month supply
1 - 60 mL (2 fl oz) bottle
Not for use by women.
-
INGREDIENTS AND APPEARANCE
MINOXIDIL EXTRA STRENGTH FOR MEN
minoxidil sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72484-097 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) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72484-097-01 3 in 1 CARTON 01/01/2024 1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 2 NDC:72484-097-02 1 in 1 CARTON 01/01/2024 2 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076239 01/01/2024 Labeler - Roman Health Ventures Inc. (081317350)