men's kirkland extra strength 5%

men's kirkland extra strength 5%
SPL v1
SPL
SPL Set ID ee71efe1-2505-4e9e-b1aa-ae8b6463596b
Route
topical
Published
Effective Date 2010-08-20
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
nda active Since 2010-07-16

Purpose

Hair regrowth treatment for men

Description

Drug Facts


Medication Information

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Purpose

Hair regrowth treatment for men

Directions
  • apply one 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
Other Information
  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed booklet
  • keep the carton. It contains important information.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
  • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
  • store at controlled room temperature 20° to 25° C (68° to 77° F)
Inactive Ingredients

alcohol, propylene glycol, purified water

Description

Drug Facts

Questions?
  • call us at 1-877-907-6424
Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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
Section 50567-7

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 regrowth is different for each person. This product will not work for all men.
Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1

Do not use if

  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline.
  • 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 and children.
  • your scalp is red, inflamed, infected, irritated, or painful
  • you use other medicines on the scalp
Section 53414-9

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

Active Ingredient

Minoxidil 5% w/v

Principal Display Panel 60 Ml Bottle Carton

KIRKLAND

Signature

MINOXIDIL

EXTRA STRENGTH FOR MEN

5% MINOXIDIL TOPICAL SOLUTION

HAIR REGROWTH

TREATMENT

Regrows

more hair than

2% Minoxidil

Topical Solution

Results may occur at 2 months

NOT FOR USE BY WOMEN

Unscented

3-60 mL (2 fl oz) Bottles


Structured Label Content

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Purpose

Hair regrowth treatment for men

Directions
  • apply one 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
Other Information (Other information)
  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed booklet
  • keep the carton. It contains important information.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
  • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
  • store at controlled room temperature 20° to 25° C (68° to 77° F)
Inactive Ingredients (Inactive ingredients)

alcohol, propylene glycol, purified water

Questions?
  • call us at 1-877-907-6424
Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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 regrowth is different for each person. This product will not work for all men.
Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)

Do not use if

  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline.
  • 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 and children.
  • your scalp is red, inflamed, infected, irritated, or painful
  • you use other medicines on the scalp
Section 53414-9 (53414-9)

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

Active Ingredient (Active ingredient)

Minoxidil 5% w/v

Principal Display Panel 60 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton)

KIRKLAND

Signature

MINOXIDIL

EXTRA STRENGTH FOR MEN

5% MINOXIDIL TOPICAL SOLUTION

HAIR REGROWTH

TREATMENT

Regrows

more hair than

2% Minoxidil

Topical Solution

Results may occur at 2 months

NOT FOR USE BY WOMEN

Unscented

3-60 mL (2 fl oz) Bottles


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)