KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% spray

KERANIQUE Hair Regrowth Treatment For Women by

Drug Labeling and Warnings

KERANIQUE Hair Regrowth Treatment For Women by is a Otc medication manufactured, distributed, or labeled by INTERNATIONAL HAIR INSTITUTE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 2% w/v

INDICATIONS & USAGE

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 of 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

• 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 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

QUESTIONS

Questions or comments?

1-888-237-4131

Open 24 hours a day, 7 days a week.

Visit website: www.keranique.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN 
minoxidil 2% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70550-578
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70550-578-01	1 in 1 BOX	07/10/2019
1		60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 70550-578-02	2 in 1 BOX	07/10/2019
2		60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 70550-578-03	3 in 1 BOX	07/10/2019
3		60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078176	07/10/2019

Labeler - INTERNATIONAL HAIR INSTITUTE (800337946)