Label: MENS KIRKLAND- minoxidil solution
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Contains inactivated NDC Code(s)
NDC Code(s): 63981-111-01 - Packager: Costco Wholesale Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 20, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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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
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.
- Directions
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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
- Questions?
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
MENS KIRKLAND EXTRA STRENGTH
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1) Minoxidil 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength alcohol (UNII: 3K9958V90M) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63981-111-01 12 in 1 TRAY 1 2 in 1 PACKAGE, COMBINATION 1 3 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 Labeler - Costco Wholesale Corporation (103391843)
