Men's Minoxidil

Men's Minoxidil
SPL v2
SPL
SPL Set ID 18547d9b-6786-426d-b98d-d70ea0f5becd
Route
TOPICAL
Published
Effective Date 2021-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-03-23

Description

Drug Facts

Purpose

Hair Regrowth for men


Medication Information

Purpose

Hair Regrowth for men

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. For use by men 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 are a woman
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • you do not know the reason for your hair loss
  • you are under 18 years of age
  • Do not use on babies or children
  • your scalp is red, inflamed, infected, irritated or painful
  • you use other medicines on the scalp
Active Ingredient

Minoxidil 5% 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

MEN'S

Minoxidil Hair Regrowth

EXTRA STREGNTH

5% MINOXIDIL

TOPICAL SOLUTION, USP

HAIR REGROWTH TREATMENT

Reactivates Hair Follicles to Stimulate Regrowth

Clinically Proven to Help Regrow Hair

Topical Solution

Unscented

For Best Results:

Apply Directly to Scalp. Use Twice Daily

One Month Supply 60mL (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 men

Warnings

For external use only. For use by men 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 are a woman
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • you do not know the reason for your hair loss
  • you are under 18 years of age
  • Do not use on babies or children
  • your scalp is red, inflamed, infected, irritated or painful
  • you use other medicines on the scalp
Active Ingredient

Minoxidil 5% 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

MEN'S

Minoxidil Hair Regrowth

EXTRA STREGNTH

5% MINOXIDIL

TOPICAL SOLUTION, USP

HAIR REGROWTH TREATMENT

Reactivates Hair Follicles to Stimulate Regrowth

Clinically Proven to Help Regrow Hair

Topical Solution

Unscented

For Best Results:

Apply Directly to Scalp. Use Twice Daily

One Month Supply 60mL (2 fl oz)

Available Custom Branded

800.445.2595

[email protected]


Advanced Ingredient Data


Raw Label Data

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