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Qilib Hair Regrowth Treatment for Men

Dosage form: solution
Ingredients: MINOXIDIL 5g in 100mL
Labeler: Galderma Laboratories, L.P.
NDC Code: 0299-4805

Qilib Hair Regrowth Treatment for Men

SPL listing data elements section

Active Ingredients

Minoxidil 5% w/v

Purpose

Hair regrowth treatment

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. 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.

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

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.

• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution, 5%.

• in clinical studies with mostly white men age 18-45 years with moderate degrees of hair loss, Minoxidil Topical Solution, 5% extra strength for men provided more hair regrowth than Minoxidil Topical Solution, 2%.

• store at controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive Ingredients:

Alcohol 30% v/v, Propylene Glycol 50% v/v, Purified Water

Questions or comments?

Call your health professional or Galderma at 1-866-735-4137

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

QILIB HAIR REGROWTH TREATMENT FOR MEN 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4805
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (MINOXIDIL) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:0299-4805-001 BOTTLE, SPRAY in 1 CARTON
160 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083412/01/2015
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIOperations
EI Inc.105803274manufacture(0299-4805)

 
Galderma Laboratories, L.P.

Medically reviewed on Jan 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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