Mens pura dor Hair Loss MD

Manufacturer
Vitals International Group
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:19

Label at a glance#

ProductMens pura dor Hair Loss MD
Active ingredientMINOXIDIL
Label structure15 sections

Dosage and administration

Directions • apply one mL with dropper 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

OTC - PURPOSE SECTION

Hair regrowth treatment for men

USE

INDICATIONS & USAGE SECTION

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

WARNINGS SECTION

For external use only. For use by men only.

Flammable: Keep away from fire or flame

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have heart disease

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions • apply one mL with dropper 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

OTHER SAFETY INFORMATION

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 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 SECTION

Alcohol, Propylene Glycol, Purified Water

OTC - QUESTIONS SECTION

Questions or comments? 855-PURADOR

• Visit Website at www.purador.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311724minoxidil 5 % Topical SolutionPSN2
311724minoxidil 50 MG/ML Topical SolutionSCD2
311724minoxidil 3 GM per 60 ML Topical SolutionSY2
311724minoxidil 5 % Topical SolutionSY2
311724minoxidil 5 GM per 100 ML Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MINOXIDIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69019-001-012025-01-30C16284748780-12cef2736-9d97-d83d-e063-dadaa90ab31fVital's International - Men's pura d'or Hair Loss Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69019-001-01Mens pura dor Hair Loss MD1 in 1 BOXSOLUTION12
69019-001-01Mens pura dor Hair Loss MD60 mL in 1 BOTTLESOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69019-001MENS PURA DOR HAIR LOSS MD (MINOXIDIL 5%) SOLUTION [VITALS INTERNATIONAL GROUP]2Legacy NDC, 2 package rows20230119_928dc0f8-e834-103e-e053-2995a90ad420.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69019-00169019-001-01

Ingredients#

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

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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076239-001THEROXIDILMINOXIDIL5%SOLUTION / TOPICAL2004-08-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2484e616aacf4f…
2026-08-18 06:07:402026-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243f01610625f2…
2019-09-15 20:21 UTC2019-09A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076239-001THEROXIDIL5%SOLUTION / TOPICAL2004-08-24f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f28bed30-758c-8f24-e053-2a95a90a41d2928dc0f8-e834-103e-e053-2995a90ad4202023-01-18WarningsExact identifier
spl id: f28bed30-758c-8f24-e053-2a95a90a41d2
spl set id: 928dc0f8-e834-103e-e053-2995a90ad420

Reported adverse events (FAERS/openFDA)#

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