Keranique 2% 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 2% Hair Regrowth Treatment for Women

Active ingredientMINOXIDIL

Label structure8 sections

Dosage and administration

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area using 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#

PhoneLabel contact1-888-237-4131

Websitewww.keranique.com

www.keranique.com

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 amount 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 you have

OTC - ASK DOCTOR/PHARMACIST SECTION

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

apply one mL with dropper 2 times a daydirectly onto the scalp in the hair loss area
using 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 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 USP 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 Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311723	minoxidil 2 % Topical Solution	PSN	4
311723	minoxidil 20 MG/ML Topical Solution	SCD	4
311723	minoxidil 2 % Topical Solution	SY	4
311723	minoxidil 2 GM per 100 ML Topical Solution	SY	4

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70550-576-01	2024-02-22	C162847	48780-1	1030e365-5e06-111a-e063-dadaa90a10e2	KERANIQUE Rejuvenate Healthy Hair Regrowth 2% For Women Dropper
70550-576-02	2024-02-22	C162847	48780-1	1030e365-5e06-111a-e063-dadaa90a10e2	KERANIQUE Rejuvenate Healthy Hair Regrowth 2% For Women Dropper
70550-576-04	2024-02-22	C162847	48780-1	1030e365-5e06-111a-e063-dadaa90a10e2	KERANIQUE Rejuvenate Healthy Hair Regrowth 2% For Women Dropper
70550-576-01	2024-01-30	C162847	48780-1	1030e365-5e06-111a-e063-dadaa90a10e2	KERANIQUE Rejuvenate Healthy Hair Regrowth 2% For Women Dropper
70550-576-02	2024-01-30	C162847	48780-1	1030e365-5e06-111a-e063-dadaa90a10e2	KERANIQUE Rejuvenate Healthy Hair Regrowth 2% For Women Dropper
70550-576-04	2024-01-30	C162847	48780-1	1030e365-5e06-111a-e063-dadaa90a10e2	KERANIQUE Rejuvenate Healthy Hair Regrowth 2% For Women Dropper

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70550-576-01	Keranique 2% Hair Regrowth Treatment for Women	1 in 1 BOX	SOLUTION	1		4
70550-576-01	Keranique 2% Hair Regrowth Treatment for Women	60 mL in 1 BOTTLE, DROPPER	SOLUTION	60		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70550-576	KERANIQUE 2% HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SOLUTION [PROFECTUS BEAUTY, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240828_c781447a-10f1-70e3-e053-2995a90a40f8.zip

Products#

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

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

Keranique 2% Hair Regrowth Treatment for Women
MINOXIDIL
ALCOHOL
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70550-576	70550-576-01

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
A078176-001	THEROXIDIL	MINOXIDIL	2%	SOLUTION / TOPICAL			2007-11-09

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`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
Keranique 2% Hair Regrowth Treatment for Women	MINOXIDIL	PROFECTUS BEAUTY, LLC	c781447a-10f1-70e3-e053-2995a90a40f8	2024-08-22	Warnings	Exact identifier ndc (package): 70550-576-01 ndc (product): 70550-576 ndc11 (package): 70550057601 spl id: 2046bd30-462c-4c46-e063-6294a90a8e59 spl set id: c781447a-10f1-70e3-e053-2995a90a40f8

Reported adverse events (FAERS/openFDA)#

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