FDA.reportPublic FDA data

KERANIQUE Hair Regrowth Treatment For Women

Manufacturer
PROFECTUS BEAUTY, LLC
Effective date
2024-08-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:17:52

Label at a glance#

ProductKERANIQUE Hair Regrowth Treatment For Women
Active ingredientMINOXIDIL
Label structure11 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 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area  using more often will not improve results continued use is necessary or hair loss will begin again

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 2% w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment

Use

INDICATIONS & USAGE SECTION

to regrow hair on the scalp

Warnings.

WARNINGS SECTION

For external use only.

Flammable:Keep away from fire or flame

Do not use if

OTC - DO NOT USE SECTION

  • your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you  
  • your have no family history of hair loss 
  • your hair loss is sudden and/or patchy
  • your hair loss is associated with childbirth 
  • you do not know the
  • reason for your hair loss 
  • you are under 18 year 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

OTC - ASK DOCTOR/PHARMACIST SECTION

you have heart disease

When using this product

OTC - WHEN USING SECTION

  • do not apply on other parts of the body 
  • avoid eye 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. You may need to use this product 2 times a day 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 everyone.

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 breastfeeding.

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 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area 
  • using more often will not improve results
  • continued use is necessary 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 booklet 
  • keep the carton. It contains important information. 
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate diagnosis of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women imported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth, 40% had minimal regrowth). This compares with 7% of women reporting incidental hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth). 
  • 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

Call toll free 1-888-237-4131 Visit website: www.keranique.com

Package Labelling:70550-578-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1.jpgLabel1.jpg

Package Labelling:70550-578-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2.jpgLabel2.jpg

Package Labelling:70550-578-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3.jpgLabel3.jpg

Package Labelling:70550-578-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4.jpgLabel4.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1537947minoxidil 2 % Topical SprayPSN4
1537947minoxidil 20 MG/ML Topical SpraySCD4
1537947minoxidil 2 % Topical SpraySY4

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
70550-578-012024-08-27C16284748780-1f386c649-b14c-0266-e053-dadaa90a7c1aKERANIQUE Rejuvenate Healthy Hair Regrowth 2% For Women
70550-578-022024-08-27C16284748780-1f386c649-b14c-0266-e053-dadaa90a7c1aKERANIQUE Rejuvenate Healthy Hair Regrowth 2% For Women
70550-578-032024-08-27C16284748780-1f386c649-b14c-0266-e053-dadaa90a7c1aKERANIQUE Rejuvenate Healthy Hair Regrowth 2% For Women

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70550-578-01KERANIQUE Hair Regrowth Treatment For Women60 mL in 1 BOTTLE, SPRAYSPRAY604
70550-578-01KERANIQUE Hair Regrowth Treatment For Women1 in 1 BOXSPRAY14
70550-578-02KERANIQUE Hair Regrowth Treatment For Women2 in 1 BOXSPRAY24
70550-578-02KERANIQUE Hair Regrowth Treatment For Women60 mL in 1 BOTTLE, SPRAYSPRAY604
70550-578-03KERANIQUE Hair Regrowth Treatment For Women3 in 1 BOXSPRAY34
70550-578-03KERANIQUE Hair Regrowth Treatment For Women60 mL in 1 BOTTLE, SPRAYSPRAY604
70550-578-04KERANIQUE Hair Regrowth Treatment For Women4 in 1 BOXSPRAY44
70550-578-04KERANIQUE Hair Regrowth Treatment For Women60 mL in 1 BOTTLE, SPRAYSPRAY604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70550-578KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SPRAY [PROFECTUS BEAUTY, LLC]4Current NDC, Legacy NDC, 8 package rows20240828_8d580c01-a13d-81f8-e053-2a95a90a7426.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
70550-57870550-578-01, 70550-578-02, 70550-578-03, 70550-578-04

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
NameUNIIKind
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
MINOXIDIL5965120SH1ACTIB

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
A078176-001THEROXIDILMINOXIDIL2%SOLUTION / TOPICAL2007-11-09

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 22:38:342026-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078176-001THEROXIDIL2%SOLUTION / TOPICAL2007-11-09f41ea6bd6efb…

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
KERANIQUE Hair Regrowth Treatment For WomenMINOXIDILPROFECTUS BEAUTY, LLC8d580c01-a13d-81f8-e053-2a95a90a74262024-08-22WarningsExact identifier
ndc (package): 70550-578-02
ndc (package): 70550-578-04
ndc (package): 70550-578-01
ndc (package): 70550-578-03
ndc (product): 70550-578
ndc11 (package): 70550057803
ndc11 (package): 70550057802
ndc11 (package): 70550057801
ndc11 (package): 70550057804
spl id: 2046653c-a5e8-c010-e063-6294a90ae442
spl set id: 8d580c01-a13d-81f8-e053-2a95a90a7426

Reported adverse events (FAERS/openFDA)#

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