Women's Minoxidil

Women's Minoxidil
SPL v2
SPL
SPL Set ID 6cd3532a-1c1d-44bb-9f7e-c9dc085e2f96
Route
TOPICAL
Published
Effective Date 2021-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (20 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-03-26

Description

Drug Facts

Purpose

Hair Regrowth for women


Medication Information

Purpose

Hair Regrowth for women

Description

Drug Facts

Use

To regrow hair on the scalp

Section 42229-5

Drug Facts

Section 44425-7

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50569-3

Ask a doctor before use if you have heart disease

Section 53414-9

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

Warnings

For external use only.

Flammable: Keep away from fire or flame

Directions

Apply one mL 2 times a day directly onto the scalp in the hair loss area

  • see enclosed leaflet for complete Directions for Use
  • using more or more often will not improve result
  • continued use is necessary, or hair loss will begin again
Questions?

Call Topiderm at 800-445-2595 or reach us on the internet at topiderm.com

Do Not Use If
  • you 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 years 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
Active Ingredient

Minoxidil 2% w/v

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

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
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 of redness occurs
  • unwanted facial hair growth occurs
Principal Display Panel 60 Ml Bottle Label

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

WOMEN'S

Minoxidil Hair Regrowth

2% MINOXIDIL TOPICAL SOLUTION, USP

HAIR REGROWTH TREATMENT

Unscented

Clinically proven to help regrow hair

Reactivates hair follicles to

stimulate regrowth

Topical Solution

One Month Supply 60 mL (2 fl oz)

Available Custom Branded

800.445.2595

[email protected]


Structured Label Content

Use

To regrow hair on the scalp

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 53414-9 (53414-9)

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

Purpose

Hair Regrowth for women

Warnings

For external use only.

Flammable: Keep away from fire or flame

Directions

Apply one mL 2 times a day directly onto the scalp in the hair loss area

  • see enclosed leaflet for complete Directions for Use
  • using more or more often will not improve result
  • continued use is necessary, or hair loss will begin again
Questions?

Call Topiderm at 800-445-2595 or reach us on the internet at topiderm.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
  • your hair loss is associated with childbirth
  • you do not know the reason for your hair loss
  • you are under 18 years 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
Active Ingredient

Minoxidil 2% w/v

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

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
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 of redness occurs
  • unwanted facial hair growth occurs
Principal Display Panel 60 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label)

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

WOMEN'S

Minoxidil Hair Regrowth

2% MINOXIDIL TOPICAL SOLUTION, USP

HAIR REGROWTH TREATMENT

Unscented

Clinically proven to help regrow hair

Reactivates hair follicles to

stimulate regrowth

Topical Solution

One Month Supply 60 mL (2 fl oz)

Available Custom Branded

800.445.2595

[email protected]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)