REGEN- 5% minoxidil topical solution solution

Regen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient

Minoxidil USP 5% w/v

Purpose

Hair regrowth treatment for men

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

For external use only.  For use by men only.

Flammable: Keep away from fire or flame

Do not use if

• you are a woman
• your amount of hair loss is different than that shown on the side of this carton, or your hair loss is on the front of the scalp.  5% minoxidil topical solution is not intended for frontal baldness or receding hairline.
• you have no family history of hair loss
• your hair loss is sudden and/or patchy
• 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, inflammed, 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 this product

• do not apply on other part of the body
• avoid contact with the eyes.  In case of accidental contact, rinse eyes with large amounts of cool tap water.
• some individuals (people) have experienced changes in hair color and/or texture
• it takes time to regrow hair.  Results may occur at 2 months with 2 times daily usage of this product.  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 all men.

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
• 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 1 mL 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 side of this carton
• before use, read all information on carton and enclosed booklet.
• keep the carton.  It contains important information.
• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solutions for men.
• In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth that 2% minoxidil topical solution.
• store at controlled room temperature 20° to 25° C (68° to 77° F)

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

Call your health professional or Follinique at 888-508-0320 Monday - Friday 9:00 AM - 5:00 PM (MST)

PRINCIPAL DISPLAY PANEL

Regen by Follinique

Men's 5% Minoxidil Topical Solution, USP

Extra Strength For Men

Hair Regrowth Treatment

Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

Unscented Topical Solution

Not for use by women

One 60 mL (2 fl oz) Bottle / One month supply

INGREDIENTS AND APPEARANCE

REGEN 
5% minoxidil topical solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70788-580
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	50 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: 70788-580-01	1 in 1 CARTON	12/01/2016
1		60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076239	12/01/2016

Labeler - Premium Distribution, LLC (079805390)