5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution

5% Minoxidil Topical Solution by

Drug Labeling and Warnings

5% Minoxidil Topical Solution by is a Otc medication manufactured, distributed, or labeled by AVACOR PRODUCTS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 5% w/v

PURPOSE

Hair regrowth treatment

INDICATIONS & USAGE

Use to regrow hair on the scalp

WARNINGS

For external use only, For use by men only.

Flammable: Keep away from fire or flame

DO NOT USE

• 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

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 of 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.

INSTRUCTIONS FOR USE

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 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 INGREDIENT

Inactive Ingredients: Alcohol, Propylene Glycol, Purified Water

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

5% MINOXIDIL TOPICAL SOLUTION 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49539-001
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49539-001-01	3 in 1 CARTON	04/01/2019
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076239	04/01/2019

Labeler - AVACOR PRODUCTS, LLC (080364950)

Registrant - AVACOR PRODUCTS, LLC (080364950)