Keranique Rejuvenate Healthy Hair Regrowth 2% For Women

Keranique Rejuvenate Healthy Hair Regrowth 2% For Women
SPL v2
SPL
SPL Set ID d8dcf6f7-5b80-4b2c-e053-2995a90a87f2
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
  • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
  • apply 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area 
  • using more often will not improve results
  • continued use is necessary or hair loss will begin again
Drug Facts

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  
  • 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 Controlled Room Temperature 20 to 25 C (68° to 77° F)
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.
Ask A Doctor Before Use If

you have heart disease

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.

Package Labelling:70550 578 01

Package Labelling:70550 578 02

Package Labelling:70550 578 03

Package Labelling:70550 578 04


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
  • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
  • apply 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area 
  • using more often will not improve results
  • continued use is necessary or hair loss will begin again
Drug Facts

Do Not Use If (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  
  • 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 Controlled Room Temperature 20 to 25 C (68° to 77° F)
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.
Ask A Doctor Before Use If (Ask a doctor before use if)

you have heart disease

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.

Package Labelling:70550 578 01 (Package Labelling:70550-578-01)

Package Labelling:70550 578 02 (Package Labelling:70550-578-02)

Package Labelling:70550 578 03 (Package Labelling:70550-578-03)

Package Labelling:70550 578 04 (Package Labelling:70550-578-04)


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