20/10/2022
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Indications and Usage
Warnings
Dosage and Administration
Drug Facts
Active ingredient
Minoxidil 5%
Purpose
Hair regrowth treatment for men
Use
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
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
• Ask a doctor before use if you have heart disease
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.
• 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
• May be harmful if used when pregnant or breast-feeding.
☆ Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
☆ Related/similar drugs
triamcinolone, minoxidil topical, Kenalog-40, baricitinib, Olumiant, Rogaine
》》》 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
》》Questions?》》
call us at +233550230796
Whatsapp +233200626246 / +233243743039
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
MENS KIRKLAND EXTRA STRENGTH
minoxidil solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Minoxidil (Minoxidil) Minoxidil 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
alcohol
propylene glycol
water
Packaging
# Item Code Package Description
1 NDC:63981-111-01 12 PACKAGE, COMBINATION (PACKAGE) in 1 TRAY
1 2 CARTON (CARTON) in 1 PACKAGE, COMBINATION
1 3 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1 60 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020834 07/16/2010
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During pregnancy
Drug class: miscellaneous topical agents
Breastfeeding
En español
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Prescribing Information
Other brands
Hair Regrowth Treatment for Men, Hair Regrowth Treatment for Women
Related treatment guides
Alopecia
Medical Disclaimer
DRUG STATUS
Availability
Rx and/or OTC
Rx
OTC
Pregnancy & Lactation
Risk data available
CSA Schedule*
Not a controlled drug
N/A
Approval History
Drug history at FDA
User Reviews & Ratings
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