MENS PURA DOR HAIR LOSS MD- minoxidil 5% solution 
Vitals International Group

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Vital's International - Men's pura d'or Hair Loss Treatment

Minoxidil 5% w/v

Hair regrowth treatment for men

USE

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

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, inflamed, irritated or painful • you use

other medicines on the scalp

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 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 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

May be harmful if used when pregnant or breast-feeding.

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 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).

Alcohol, Propylene Glycol, Purified Water

Questions or comments? 855-PURADOR

• Visit Website at www.purador.com

Box

MENS PURA DOR HAIR LOSS MD 
minoxidil 5% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69019-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69019-001-011 in 1 BOX09/27/2019
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623909/27/2019
Labeler - Vitals International Group (049656991)

Revised: 1/2023
Document Id: f28bed30-758c-8f24-e053-2a95a90a41d2
Set id: 928dc0f8-e834-103e-e053-2995a90ad420
Version: 2
Effective Time: 20230118
 
Vitals International Group