SPL listing data elements section Qilib Hair Regrowth Treatment for Men MINOXIDIL MINOXIDIL MINOXIDIL ALCOHOL PROPYLENE GLYCOL WATER Qilib for Men Carton
Drug Facts
Composition & Profile
Identifiers & Packaging
Package Label GALDERMA qilib ™ Extra strength 5% MINOXIDIL TOPICAL SOLUTION HAIR REGROWTH TREATMENT FOR MEN REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH • Clinically proven to help regrow hair • Spray solution for easy application • Unscented Not for use by women EASY TO USE SPRAY BOTTLE 1 month supply 1 - 60mL (2 FL OZ) Bottle GALDERMA qilib ™ HAIR REGROWTH TREATMENT FOR MEN 5% MINOXIDIL TOPICAL SOLUTION Revitalizes Hair Follicles (Read enclosed leaflet before use) Drug Facts This Package Contains: • One 60 mL (2 FL OZ) Bottle of Qilib Hair Regrowth Treatment For Women (one month supply). • This package also contains an educational booklet. Qilib Hair Regrowth Treatment For Men (Minoxidil Topical Solution 5%) For men who have a general thinning of hair on the top of the scalp (vertex only as shown below). Not intended for frontal baldness or a receding hairline. 5% Minoxidil Topical Solution has been shown to regrow hair in men with the following degrees of thinning hair or hair loss: If men have more hair loss or hair loss in a place different than shown above, Qilib Hair Regrowth Treatment For Men may not work. qilib ™ Actual Size of 60 mL (2 FL OZ) 5% MINOXIDIL TOPICAL SOLUTION Distributed by: Galderma Laboratories, LP. Fort Worth, Texas 76177 USA All trademarks are the property of thier respective owners P52977-0
- Package Label GALDERMA qilib ™ Extra strength 5% MINOXIDIL TOPICAL SOLUTION HAIR REGROWTH TREATMENT FOR MEN REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH • Clinically proven to help regrow hair • Spray solution for easy application • Unscented Not for use by women EASY TO USE SPRAY BOTTLE 1 month supply 1 - 60mL (2 FL OZ) Bottle GALDERMA qilib ™ HAIR REGROWTH TREATMENT FOR MEN 5% MINOXIDIL TOPICAL SOLUTION Revitalizes Hair Follicles (Read enclosed leaflet before use) Drug Facts This Package Contains: • One 60 mL (2 FL OZ) Bottle of Qilib Hair Regrowth Treatment For Women (one month supply). • This package also contains an educational booklet. Qilib Hair Regrowth Treatment For Men (Minoxidil Topical Solution 5%) For men who have a general thinning of hair on the top of the scalp (vertex only as shown below). Not intended for frontal baldness or a receding hairline. 5% Minoxidil Topical Solution has been shown to regrow hair in men with the following degrees of thinning hair or hair loss: If men have more hair loss or hair loss in a place different than shown above, Qilib Hair Regrowth Treatment For Men may not work. qilib ™ Actual Size of 60 mL (2 FL OZ) 5% MINOXIDIL TOPICAL SOLUTION Distributed by: Galderma Laboratories, LP. Fort Worth, Texas 76177 USA All trademarks are the property of thier respective owners P52977-0
Overview
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).
Indications & Usage
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).
Dosage & Administration
Directions • apply 1 mL with sprayer (6 sprays) 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
Warnings & Precautions
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. Minoxidil Topical Solution, 5% 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 hairloss • you are under 18 years of age. Do not use on babies and children • your scalp is red, inflamed, 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 wtih the eyes. In cases 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 wtih 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 • side effects occur: You may report side effects to FDA at 1-800-FDA-1088 or to Galderma at 1-866-735-4137. • 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose
Purpose Hair regrowth treatment
Keep Out of Reach of Children
For external use only. For use by men only. Flammable: Keep away from fire or flame.
Questions
Questions or comments? Call your health professional or Galderma at 1-866-735-4137
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