Boe Minoxidil

Boe Minoxidil
SPL v2
SPL
SPL Set ID 3d493e10-9cd9-6e2b-e063-6294a90a6d6c
Route
TOPICAL
Published
Effective Date 2024-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (1 mL)
Inactive Ingredients
Propylene Glycol Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-25

Description

MINOXIDIL 5%

Purpose

Active ingredients Purpose Minoxidil 5% W/V Enhance hair appearance Use : Promote the appearence of fuller hair.


Medication Information

Warnings and Precautions

For External Use Only

Flammable: Keep away from fire or flame

Indications and Usage

use as directed

Purpose
Active ingredients Purpose
Minoxidil 5% W/V Enhance hair appearance

Use: Promote the appearence of fuller hair.

Description

MINOXIDIL 5%

Section 50565-1

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 51727-6

Alcohol, propylene glycol, purified water.

Section 51945-4

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

Directions
  • 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

Questions?
  • Call (201) 608-5108
  • Visit www.boeusa.com
Do Not Use If
  • 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.
Other 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.
Pregnancy Section

May be harmful if used when pregnant or breast-feeding.

Active Ingredients

MINOXIDIL 5%

When Using This Product
  • 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.
Stop Use and Ask A Doctor If
  • 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.
Ask A Doctor Before Use If You Have

heart disease


Structured Label Content

Indications and Usage (34067-9)

use as directed

Warnings and Precautions (34071-1)

For External Use Only

Flammable: Keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 51727-6 (51727-6)

Alcohol, propylene glycol, purified water.

Section 51945-4 (51945-4)

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

Purpose
Active ingredients Purpose
Minoxidil 5% W/V Enhance hair appearance

Use: Promote the appearence of fuller hair.

Directions
  • 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

Questions?
  • Call (201) 608-5108
  • Visit www.boeusa.com
Do Not Use If (Do not use if)
  • 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.
Other Information (Other 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.
Pregnancy Section (Pregnancy section)

May be harmful if used when pregnant or breast-feeding.

Active Ingredients (Active ingredients)

MINOXIDIL 5%

When Using This Product (When using this product)
  • 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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease


Advanced Ingredient Data


Raw Label Data

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