KERANIQUE FOR WOMEN HAIR REGROWTH TREATMENT- minoxidil liquid

KERANIQUE For Women Hair Regrowth Treatment by

Drug Labeling and Warnings

KERANIQUE For Women Hair Regrowth Treatment by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

KERANIQUE FOR WOMEN HAIR REGROWTH TREATMENT 
minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-562
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	20 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: 65121-562-02	1 in 1 CARTON	02/10/2017
1		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078176	02/06/2014

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-562) , repack(65121-562)