KERANIQUE For Women Hair Regrowth Treatment

Medically reviewed by Drugs.com. Last updated on Jan 31, 2020.

Dosage form: liquid

Ingredients: MINOXIDIL 20mg in 1mL

Labeler: Pure Source, LLC

NDC Code: 65121-562

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 o C. (68 o - 77 o F). 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 Type HUMAN OTC DRUG Item Code (Source) NDC:65121-562 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (MINOXIDIL) MINOXIDIL 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL PROPYLENE GLYCOL WATER Packaging # Item Code Package Description 1 NDC:65121-562-02 1 BOTTLE, DROPPER in 1 CARTON 1 60 mL in 1 BOTTLE, DROPPER 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 Operations Pure Source, LLC 080354456 manufacture(65121-562), repack(65121-562)

Pure Source, LLC

Further information

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

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