DANIEL ALAIN EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN- minoxidil 5% solution 
Daniel Alain, Inc

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Daniel Alain Men's Extra Strength 5% Minoxidil Topical Solution

Minoxidil 5% w/v

Hair regrowth treatment for men

USE

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

For external use only. For use by men only.

Flammable Keep away from fire or flame.

Do not use if

Ask a doctor before use if you have heart disease

When using this product

Stop use and ask doctor if

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

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

• 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 68º to 77ºF (20º to 25ºC).

Alcohol, Propylene Glycol, Purified Water

Questions or comments, call toll-free 1-888-436-5532

Visit website: www.danielalain.com

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DANIEL ALAIN EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN 
minoxidil 5% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82545-002
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
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82545-002-011 in 1 BOX02/04/2022
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623902/04/2022
Labeler - Daniel Alain, Inc (010990313)

Revised: 2/2022
Document Id: d738eb33-5aeb-66bf-e053-2995a90a5e11
Set id: d738eb33-5aea-66bf-e053-2995a90a5e11
Version: 1
Effective Time: 20220204
 
Daniel Alain, Inc