KERANIQUE Hair Regrowth Treatment For Women MINOXIDIL PROFECTUS BEAUTY, LLC FDA Approved Use to regrow hair on the scalp
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Substance Minoxidil
Route
TOPICAL
Applications
ANDA078176

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient Minoxidil 2% w/v Purpose Hair regrowth treatment
Inactive Ingredients
Inactive Ingredients Alcohol Propylene Glycol Purified Water
Strengths
2 %
Treats Conditions
Use To Regrow Hair On The Scalp

Identifiers & Packaging

Container Type UNKNOWN
UNII
5965120SH1
Packaging

Package Labelling:70550-578-01 Label1.jpg; Package Labelling:70550-578-02 Label2.jpg; Package Labelling:70550-578-03 Label3.jpg; Package Labelling:70550-578-04 Label4.jpg

Package Descriptions
  • Package Labelling:70550-578-01 Label1.jpg
  • Package Labelling:70550-578-02 Label2.jpg
  • Package Labelling:70550-578-03 Label3.jpg
  • Package Labelling:70550-578-04 Label4.jpg

Overview

Use to regrow hair on the scalp

Indications & Usage

Use to regrow hair on the scalp

Dosage & Administration

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

Warnings & Precautions
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 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 Ask a doctor before use if you have heart disease 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 May be harmful if used when pregnant or breastfeeding. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Hair regrowth treatment

Do Not Use

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

When Using

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 & Ask a Doctor

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.

Questions

Questions or Comments? Call toll free 1-888-237-4131 Visit website: www.keranique.com


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