KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% solution

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 2% w/v
USE

Use to regrow hair on the scalp
PURPOSE

Hair regrowth treatment
WARNINGS

For external use only.

Flamable: Keep away from fire of flame.
DO NOT USE
Do not use if:
- Your degree of hair loss is different than 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 or children
- Your scalp is red, inflamed, infected, irritated, or painful
- You use other medicines on the scalp
ASK DOCTOR

Ask a doctor before use if you have heart disease
WHEN USING
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 expereinced changes in hair color and/or texture
- It takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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
Stop use and ask a doctor if
- Chest pain, rapid heart beat, faintness, or dissiness occurs. Sudden, unexplained weight gain occurs
- Your hands or feet swell
- Scalp irritation or redness occurs
- You get unwanted facial hair growth
- You do not see hair regrowth in 4 months
PREGNANCY OR BREAST FEEDING

May be harmful if used when pregnant or breast-feeding.
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.
DIRECTIONS
- apply 1mL 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 the side of this carton
- Before use, read all information on carton and enclosed leaflet
- Keep the carton. It contains important information
- In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
- Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)
INACTIVE INGREDIENT

Alcohol, Propylene Glycol, Purified Water
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN
minoxidil 2% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-578
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 65121-578-04	4 in 1 BOX	09/13/2022
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078176	09/13/2022

Labeler - Pure Source, LLC (080354456)

KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% solution

KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN by

Drug Labeling and Warnings

Drug Details [pdf]