FDA.reportPublic FDA data

SOLUCION CAPILAR CRECEPELO

Manufacturer
BOE Dominicana SRL
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:57

Label at a glance#

ProductSOLUCION CAPILAR CRECEPELO
Active ingredientMINOXIDIL
Label structure9 sections

Dosage and administration

Apply one (1) 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#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

MINOXIDIL 5%

Purpose

OTC - PURPOSE SECTION

Active ingredientsPurpose
Minoxidil 5% W/VEnhance hair appearance

Use: Promote the appearence of fuller hair.

WARNINGS SECTION

For External Use Only

Flammable: Keep away from fire or flame

Do not use if

OTC - DO NOT USE SECTION

  • You have no family history of hair loss .
  • Your hair loss is sudden and/or patchy ·
  • You do not know the reason for you hair loss. ·
  • You are under 18 years of age.
  • Do not use in babies or children. ·
  • Your scalp is red, inflamed, infected, irritated, or painful.

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 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 is different for each person. This product will not work for all men.

Pregnancy section

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. (1-800-222-1222)

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.

Other information

OTHER SAFETY INFORMATION

  • Before use, read all information on carton.
  • Keep the carton. It contains important information.
  • Store at 20° to 25°C (68° to 77°F). Keep tightly closed.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply one (1) 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

INDICATIONS & USAGE SECTION

use as directed

INACTIVE INGREDIENT SECTION

Alcohol, propylene glycol, purified water.

Questions?

OTC - QUESTIONS SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 78192-400-01

CRECEPELO®

MINOXIDIL

Enhances Hair Density Appearance

Mejora la apariencia de la densidad del cabello

TOPICAL SOLUTION USP 5%

Solución tópica USP, 5%

Helps hair look thicker and more voluminous.

Helps reduce the appearance of thinning hair

Boost hair volume and texture

Ayuda a que el cabello luzca más grueso y voluminoso. Ayuda a reducir la apariencia de cabello fino. Promueve el volumen y la textura del cabello

NOT FOR WOMEN

3 MONTH SUPPLY

Tratamiento de 3 mes

4 ampules 0.7 fl oz. each (92 mL)

Manufactured & Packed by: Boé Dominicana SRL, Ctra. de Ceuta km2, Santo Domingo Norte, RD

Distributed by: Boé Cosmetics USA Corporation, 73 Williams Street Belleville, NJ07109

MINOXMINOX

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
78192-401-01SOLUCION CAPILAR CRECEPELO23 mL in 1 BOTTLE, DROPPERLIQUID232
78192-401-01SOLUCION CAPILAR CRECEPELO4 in 1 CARTONLIQUID42

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
78192-40178192-401-01

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
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
MINOXIDIL5965120SH1ACTIB

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
SOLUCION CAPILAR CRECEPELOMINOXIDILBOE Dominicana SRL3d493e10-9cd9-6e2b-e063-6294a90a6d6c2025-01-28WarningsExact identifier
ndc (package): 78192-401-01
ndc (product): 78192-401
ndc11 (package): 78192040101
spl id: 3d490b9b-1c92-1b07-e063-6294a90a5355
spl set id: 3d493e10-9cd9-6e2b-e063-6294a90a6d6c

Reported adverse events (FAERS/openFDA)#

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