Keranique Rejuvenate Healthy Hair Regrowth 2% For Women Dropper

Keranique Rejuvenate Healthy Hair Regrowth 2% For Women Dropper
SPL v4
SPL
SPL Set ID c781447a-10f1-70e3-e053-2995a90a40f8
Route
TOPICAL
Published
Effective Date 2024-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (20 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-07-17

Description

Minoxidil 2% w/v

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

Minoxidil 2% w/v

Use

to regrow hair on the scalp

Warnings.

For external use only.

Flammable:Keep away from fire or flame

Directions
  • apply one mL with dropper 2 times a daydirectly onto the scalp in the hair loss area
  • using more often will not improve results
  • continued use is necessary to increase and keep your hair regrowth or hair loss will begin again.
Drug Facts

Do Not Use If
  • your amount of hair loss is different than that shown on the side of this carton, because this product may not work for you
  • your 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 year 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
Active Ingredient

Minoxidil 2% w/v

Other Information
  • see hair loss pictures on side of this carton 
  • before use, read all information on carton and enclosed booklet
  • keep the carton. It contains important information.
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate diagnosis of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women imported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth, 40% had minimal regrowth). This compares with 7% of women reporting incidental 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 to 25 C (68° to 77° F)
Package Labeling:

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments?

Call toll free 1-888-237-4131 Visit website: www.keranique.com

When Using This Product
  • do not apply on other parts of the body
  • avoid eye 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 hands or feet swell
  • scalp irritation or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth in 4 months
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

heart disease

May Be Harmful If Used When Pregnant Or Breastfeeding


Structured Label Content

Use

to regrow hair on the scalp

Purpose

Hair regrowth treatment

Warnings.

For external use only.

Flammable:Keep away from fire or flame

Directions
  • apply one mL with dropper 2 times a daydirectly onto the scalp in the hair loss area
  • using more often will not improve results
  • continued use is necessary to increase and keep your hair regrowth or hair loss will begin again.
Drug Facts

Do Not Use If (Do not use if)
  • your amount of hair loss is different than that shown on the side of this carton, because this product may not work for you
  • your 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 year 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
Active Ingredient

Minoxidil 2% w/v

Other Information
  • see hair loss pictures on side of this carton 
  • before use, read all information on carton and enclosed booklet
  • keep the carton. It contains important information.
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate diagnosis of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women imported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth, 40% had minimal regrowth). This compares with 7% of women reporting incidental 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 to 25 C (68° to 77° F)
Package Labeling:

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments? (Questions or Comments?)

Call toll free 1-888-237-4131 Visit website: www.keranique.com

When Using This Product (When using this product)
  • do not apply on other parts of the body
  • avoid eye 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 (Stop use and ask a doctor if)
  • 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
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease

May Be Harmful If Used When Pregnant Or Breastfeeding (May be harmful if used when pregnant or breastfeeding)


Advanced Ingredient Data


Raw Label Data

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