PROBLIVA MENS EXTRA STRENGTH MINOXIDIL- minoxidil solution

ProBliva Mens Extra Strength Minoxidil by

Drug Labeling and Warnings

ProBliva Mens Extra Strength Minoxidil by is a Otc medication manufactured, distributed, or labeled by CAVTECH HOLDING LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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.

FlammableKeep away from fire or flame

Do not use if:

you are a woman  you have no family history of hair loss  your hair loss is sudden and/or patchy  you do not know the reason for your 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

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  unwated facial hair growth occurs

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

prime the sprayer by holding the bottle upright and 5 times to ensure delivery of full spray. Do not inhale mist  apply one mL with spray (6 sprays) 2 times a daydirectly 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 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 treament with 5% minoxidil topical solution for men  in clinical studies of mostly white men aged 18-45 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

Questions or comments?

1-718-2907390  Visit Website at www.problivabeauty.com

Package Labeling:

INGREDIENTS AND APPEARANCE

PROBLIVA MENS EXTRA STRENGTH MINOXIDIL 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85464-595
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
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85464-595-00	1 in 1 BOX	04/04/2025
1		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	04/04/2025

Labeler - CAVTECH HOLDING LLC (036307067)

Registrant - Pure Source, LLC (080354456)