Elevate Hair Regrowth Treatment 5% Spray

Manufacturer
VAPOR PRO SHOPPE, LLC
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:32:25

Label at a glance#

ProductElevate Hair Regrowth Treatment 5
Active ingredientMINOXIDIL
Label structure8 sections

Dosage and administration

prime the sprayer by holding 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 results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. For use by men only.

Flammable:Keep away from fire or flame.

Do not use if:

OTC - DO NOT USE SECTION

  • 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
  • you 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.

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
  • unwanted facial hair growth occurs
  • you do not see hair regrowth in 4 months

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 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 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 treatment with 5% minoxidil topical solution for men
  • in clinical studies of mostly white men aged 18-45 years with moderte 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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1Label3Label3Label4Label4Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1537948minoxidil 5 % Topical SprayPSN2
1537948minoxidil 50 MG/ML Topical SpraySCD2
1537948minoxidil 5 % Topical SpraySY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84561-524-00Elevate Hair Regrowth Treatment 560 mL in 1 BOTTLE, SPRAYSOLUTION602
84561-524-00Elevate Hair Regrowth Treatment 51 in 1 BOXSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84561-524ELEVATE HAIR REGROWTH TREATMENT 5 (MINOXIDIL) SOLUTION [VAPOR PRO SHOPPE, LLC]2Current NDC, 2 package rows20241102_0d5e4258-a58d-4378-9be8-631114588cdb.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84561-52484561-524-00

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
Elevate Hair Regrowth Treatment 5MINOXIDILVAPOR PRO SHOPPE, LLC0d5e4258-a58d-4378-9be8-631114588cdb2024-10-31WarningsExact identifier
ndc (package): 84561-524-00
ndc (product): 84561-524
ndc11 (package): 84561052400
spl id: 25d0836a-9506-d6a2-e063-6394a90aaa8f
spl set id: 0d5e4258-a58d-4378-9be8-631114588cdb

Reported adverse events (FAERS/openFDA)#

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