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KERANIQUE For Women Hair Regrowth Treatment

Dosage form: liquid
Ingredients: MINOXIDIL 20mg in 1mL
Labeler: Pure Source, LLC
NDC Code: 65121-562

KERANIQUE For Women Hair Regrowth Treatment

KERANIQUE For Women Hair Regrowth Treatment


Active ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on the scalp

Warnings

For external use only
Flammable: Keep away from fire or flame

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 hair loss is associated with childbirth
  • 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. 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
  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • sudden, unexplained weight gain occurs
  • your hand 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.

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 leaflet
  • keep the carton. It contains important information.
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solutions 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth: 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth: 33 % had minimal regrowth).
  • store at USP controlled room temperature 20 o - 25 oC. (68 o - 77 oF). Keep tightly closed.

Inactive ingredients

alcohol, propylene glycol, purified water

Questions or comments?

1-888-237-4131

KERANIQUE For Women Hair Regrowth Treatment 2-60ml (65121-562-02)

KERANIQUE FOR WOMEN HAIR REGROWTH TREATMENT 
minoxidil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-562
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (MINOXIDIL) MINOXIDIL20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:65121-562-021 BOTTLE, DROPPER in 1 CARTON
160 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07817602/06/2014
Labeler - Pure Source, LLC (080354456)
Establishment
NameAddressID/FEIOperations
Pure Source, LLC080354456manufacture(65121-562), repack(65121-562)

 
Pure Source, LLC

Medically reviewed on Feb 10, 2017

Further information

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

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