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5% Minoxidil Topical Solution

Medically reviewed by Drugs.com. Last updated on March 22, 2021.

Dosage form: solution
Ingredients: MINOXIDIL 5g in 100mL
Labeler: AVACOR PRODUCTS, LLC
NDC Code: 49539-001

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

  • 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

• 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

5% MINOXIDIL TOPICAL SOLUTION 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49539-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (MINOXIDIL) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:49539-001-013 BOTTLE in 1 CARTON
160 mL in 1 BOTTLE
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)

 
AVACOR PRODUCTS, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.