5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution 
AVACOR PRODUCTS, LLC

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AVACOR - 5% Minoxidil Topical Solution, USP

Minoxidil 5% w/v

Hair regrowth treatment

Use to regrow hair on the scalp

For external use only, For use by men only.

Flammable: Keep away from fire or flame

Ask a doctor before use if you have heart disease

• 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 of 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

• 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 age 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 USP controlled room temperature 20º to 25ºC (68º to 77ºF).

Inactive Ingredients: Alcohol, Propylene Glycol, Purified Water

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

Avacor product label

5% MINOXIDIL TOPICAL SOLUTION 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49539-001
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
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49539-001-013 in 1 CARTON04/01/2019
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623904/01/2019
Labeler - AVACOR PRODUCTS, LLC (080364950)
Registrant - AVACOR PRODUCTS, LLC (080364950)

Revised: 4/2019
Document Id: 857b9644-009c-6f66-e053-2991aa0af011
Set id: 857b9644-009b-6f66-e053-2991aa0af011
Version: 1
Effective Time: 20190401
 
AVACOR PRODUCTS, LLC