MENS PURA DOR HAIR LOSS MD- minoxidil 5% solution

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 5% w/v
PURPOSE

Hair regrowth treatment for men
USE

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

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, inflamed, 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

experienced 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 all men.
STOP USE

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

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

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 SAFETY INFORMATION

Other information see hair loss pictures on side of this carton

before use, read all information on carton and enclosed leaflet 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

solution for men in clinical studies of mostly white men aged 18-49 years with

moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair

regrowth than 2% minoxidil topical solution

store at controlled room temperature 20º to 25ºC (68º to 77ºF).
INACTIVE INGREDIENT

Alcohol, Propylene Glycol, Purified Water
QUESTIONS

Questions or comments? 855-PURADOR

Visit Website at www.purador.com
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENS PURA DOR HAIR LOSS MD
minoxidil 5% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69019-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 69019-001-01	1 in 1 BOX	09/27/2019
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	ANDA076239	09/27/2019

Labeler - Vitals International Group (049656991)

MENS PURA DOR HAIR LOSS MD- minoxidil 5% solution

Mens pura dor Hair Loss MD by

Drug Labeling and Warnings

Drug Details [pdf]