FOLLINIQUE- minoxidil solution

Follinique by

Drug Labeling and Warnings

Follinique by is a Otc medication manufactured, distributed, or labeled by Premium Distribution, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients:

Minoxidil 2.0% 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 degree of hair loss is different than that 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 and children.
• your scalp is red, inflamed, infected, irritated, or painful
• you use other medications on the scalp

ASK DOCTOR

Ask a doctor before use if you have heart disease.

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 waler.
• 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 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

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a health professional before use.

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 one mL 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 side of this carton
• before use, read all information on carton and enclosed leaflet
• in clinical research in mostly white women age 18-45 years with mild to moderate degrees of hair loss, the following response to Minoxidil Topical Solution 2% was reported: 19% of women reported moderate hair regrowth after using women's Minoxidil Topical Solution 2% for 8 months; 19% had moderate regrowth; 40% had minimal regrowth. This compares with 7% of women reporting hair regrowth after using the placebo, the liquid without Minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth)
• keep the carton. It contains important information.
• store at controlled room temperature 200 to 250C (680 to 770F).

Inactive Ingredients:

alcohol , propylene glycol, purified water.

Questions or comments?

877-279-9024

Visit website at www.follinique.com

PRINCIPAL DISPLAY PANEL

NDC: 70788-579-01

Follinique

Women's 2% Minoxidil Topical Solution USP

Hair Regrowth Treatment

Reactivates Hair Follicles to Stimulate Regrowth

Clinically Proven to Help Regrow Hair

Unscented Topical Solution

INGREDIENTS AND APPEARANCE

FOLLINIQUE 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70788-579
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
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70788-579-01	1 in 1 CARTON	10/27/2016
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	10/27/2016

Labeler - Premium Distribution, LLC (079805390)