FDA.reportPublic FDA data

hair growth solution

Manufacturer
LABORATORIO MK SRL | SONIA ORGANICS
Effective date
2025-08-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:12:04

Label at a glance#

Producthair growth solution
Active ingredientMINOXIDIL
Label structure8 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Apply 1ml (20 drops) one to two times a day to the beard or scalp area, which must be dry, massage lightly and then wash your hands. Do not remove or use dryers. ( Do not exceed the indicated amount)

DirectionsDirections

INACTIVE INGREDIENT SECTION

Alcohol, Propylen Glycol, Purified Water. ingredientsingredients

WARNINGS SECTION

Avoid eyes contact, if occurs, rinse with plenty of water. Do not apply to irritated scalp. If yoy experience any allergic reaction discard its use and consult your doctor. Do not eat.

warningwarning

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Customer Service USA (917)508-6002 Customer Service RD (809)379-0900 www.mkcosmeticos.comCustomer Service USA (917)508-6002 Customer Service RD (809)379-0900 www.mkcosmeticos.com

DOSAGE & ADMINISTRATION SECTION

Apply 1ml (20 drops) one to two times a day to the beard or scalp area. Apply 1ml (20 drops) one to two times a day to the beard or scalp area.Apply 1ml (20 drops) one to two times a day to the beard or scalp area.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, for external use only.

WarningWarning

OTC - PURPOSE SECTION

Topical solution to growth and help prevent hair and beard loss. Revitalizes hair follicles and stimulates growth.Topical solution to growth and help prevent hair and beard loss. Revitalizes hair follicles and stimulates growth.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

topical solution to growth and help prevent hair and beard loss. Revitalizes hair follicles and stimulates growth.topical solution to growth and help prevent hair and beard loss. Revitalizes hair follicles and stimulates growth.

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87022-006-21hair growth solution20 mL in 1 BOTTLELIQUID203
87022-006-22hair growth solution120 mL in 1 BOXLIQUID1203

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
87022-00687022-006-21, 87022-006-22

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
WATER059QF0KO0RIACT
MINOXIDIL5965120SH1ACTIB
ALCOHOL 50%DW4WDF59APIACT
PROPYLENE GLYCOL 1,2-DISTEARATET65PN3O37HIACT

Source Document#

Source XML

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
hair growth solutionMINOXIDILLABORATORIO MK SRL3c3f84da-c4bc-36ac-e063-6394a90aa8d12025-08-29WarningsExact identifier
ndc (package): 87022-006-22
ndc (package): 87022-006-21
ndc (product): 87022-006
ndc11 (package): 87022000621
ndc11 (package): 87022000622
spl id: 3d84e916-85db-c89f-e063-6394a90a66e7
spl set id: 3c3f84da-c4bc-36ac-e063-6394a90aa8d1

Reported adverse events (FAERS/openFDA)#

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