![QILIB HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL) SOLUTION [GALDERMA LABORATORIES, L.P.]](https://medic.hrt.org//dailymed/images/b84cffaa-0435-4718-bde2-00cf28ae4b42/p52974-0-qilib-2-womens-crtn.jpg)
| NDC | 0299-4820-00 |
| Set ID | b84cffaa-0435-4718-bde2-00cf28ae4b42 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Galderma Laboratories, L.P. |
| Generic Name | |
| Product Class | Arteriolar Vasodilator |
| Product Number | |
| Application Number | NDA020834 |
- Active Ingredients
- Purpose
- Use
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Warnings
Do not use if
• your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
• you have no family history of hair loss
• your hair loss is sudden and/or patchy
• your hairloss is associated with childbirth
• 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
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. You may need to use this product 2 times a day 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 everyone
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
• unwanted facial hair growth occurs
• you do not see hair regrowth in 4 months
- 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 leaflet.
• keep the carton. It contains important information.
• in clinical studies with mostly white women age 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using women's minoxidil topical solution 2% for 8 months; 19% had moderate regrowth; 40% had minimal regrowth. This compares wtih 7% of women reporting hair regrowth after using the placebo, the liquid without the minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth).
• store at controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.
- Inactive Ingredients:
- Questions or comments?
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Package Label
GALDERMA
qilib™
2% MINOXIDIL
TOPICAL SOLUTION
HAIR REGROWTH
TREATMENT
FOR WOMEN
REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH
• Clinically proven to help regrow hair
• Spray solution for easy application
• Unscented
EASY TO USE
SPRAY BOTTLE
1 month supply
1 - 60mL (2 FL OZ) Bottle
GALDERMA
qilib™
HAIR REGROWTH
TREATMENT
FOR WOMEN
2% 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 Women (2% Minoxidil Topical Solution) is for women who have a general thinning on the top of the scalp (vertex only as shown below). 2% Minoxidil Topical Solution has been shown to regrow hair in women with the following degrees of thinning hair or hair loss:
If women have more hair loss than shown above, Qilib Hair Regrowth Treatment For Women may not work.
Do not use if you have patchy hair loss as shown below.
qilib™
Actual Size of 60 mL (2 FL OZ)
2% MINOXIDIL TOPICAL SOLUTION
Distributed by:
Galderma Laboratories, LP.
Fort Worth, Texas 76177 USA
All trademarks are the property of thier respective owners
P52974-0
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INGREDIENTS AND APPEARANCE
QILIB HAIR REGROWTH TREATMENT FOR WOMEN
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0299-4820 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 2 g in 100 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:0299-4820-00 1 in 1 CARTON 12/01/2015 04/28/2017 1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020834 12/01/2015 Labeler - Galderma Laboratories, L.P. (047350186) Establishment Name Address ID/FEI Business Operations EI Inc. 105803274 manufacture(0299-4820)