ProBliva Men's Extra Strength 5% Minoxidil Topical Solution

Manufacturer: CAVTECH HOLDING LLC | Pure Source, LLC
Effective date: 2025-04-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:59:36

Label at a glance#

ProductProBliva Mens Extra Strength Minoxidil

Active ingredientMINOXIDIL

Label structure8 sections

Dosage and administration

• 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 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

Contacts and useful links#

Websitewww.problivabeauty.com

www.problivabeauty.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for men

Use

INDICATIONS & USAGE SECTION

to regrow hair on the scalp (vertex only, see picture on side of carton)

Warnings

WARNINGS SECTION

For external use only. For use by men only.

FlammableKeep away from fire or flame

Do not use if:

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

heart disease

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageInner PackageBox0Box2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311724	minoxidil 5 % Topical Solution	PSN	1
311724	minoxidil 50 MG/ML Topical Solution	SCD	1
311724	minoxidil 3 GM per 60 ML Topical Solution	SY	1
311724	minoxidil 5 % Topical Solution	SY	1
311724	minoxidil 5 GM per 100 ML Topical Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MINOXIDIL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85464-595-00	ProBliva Mens Extra Strength Minoxidil	1 in 1 BOX	SOLUTION	1		1
85464-595-00	ProBliva Mens Extra Strength Minoxidil	60 mL in 1 BOTTLE, SPRAY	SOLUTION	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85464-595	PROBLIVA MENS EXTRA STRENGTH MINOXIDIL (MINOXIDIL) SOLUTION [CAVTECH HOLDING LLC]	1	Current NDC, 2 package rows	20250425_84a2f311-e74c-4b50-bc55-dac604ca7694.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

ProBliva Mens Extra Strength Minoxidil
MINOXIDIL
ALCOHOL
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85464-595	85464-595-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
MINOXIDIL	5965120SH1	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076239-001	THEROXIDIL	MINOXIDIL	5%	SOLUTION / TOPICAL			2004-08-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ProBliva Mens Extra Strength Minoxidil	MINOXIDIL	CAVTECH HOLDING LLC	84a2f311-e74c-4b50-bc55-dac604ca7694	2025-04-21	Warnings	Exact identifier ndc (package): 85464-595-00 ndc (product): 85464-595 ndc11 (package): 85464059500 spl id: 33487e51-fb8b-0bea-e063-6294a90a728e spl set id: 84a2f311-e74c-4b50-bc55-dac604ca7694

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.