KERANIQUE 2% HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil solution

Keranique 2% Hair Regrowth Treatment for Women by

Drug Labeling and Warnings

Keranique 2% Hair Regrowth Treatment for Women by is a Otc medication manufactured, distributed, or labeled by Profectus Beauty LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 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

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.

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.

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)

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions or Comments?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

KERANIQUE 2% HAIR REGROWTH TREATMENT FOR WOMEN 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70550-576
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: 70550-576-01	1 in 1 BOX	07/17/2024
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	07/17/2024

Labeler - PROFECTUS BEAUTY, LLC (118310694)