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Minoxidil by Hi-Tech Pharmacal Co., Inc.

Medically reviewed on August 28, 2017

Dosage form: solution
Ingredients: MINOXIDIL 2g in 100mL
Labeler: Hi-Tech Pharmacal Co., Inc.
NDC Code: 50383-001

Drug Facts

Active ingredient

Minoxidil 2% w/

Purpose

Hair regrowth treatment

Keep Out of Reach of Children

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

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

Warnings

For external use only

Flammable: Keep away from fire or flame

Do no use if
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. Minoxidil topical solution 2% 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, infected, 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. You may need to use this product 2 times a day 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 everyone

Stop use and ask a doctor if
chest pain, rapid heartbeat, faintness, or dizziness occurs
sudden, unexplained weight gain occurs
your feet or hands swell
scalp irritation or redness occurs
unwanted facial hair growth occurs
you do not see hair regrowth in 4 months

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
continues 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 insert
keep the carton. It contains important information.
In clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, the following response to minoxidil topical solution was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical solution for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth).
store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive Ingredients

alcohol (60% v/v), propylene glycol, purified water

Questions or comments?

If you have any questions, ask your healthcare professional or call us at 1-800-262-9010.

PackageLabel Principal Display Panel

NDC 50383-001-02

Minoxidil Topical Solution, USP 2%

Regular Strength Hair Regrowth Treatment

FOR MEN

Clinically Proven to Help Regrow Hair

Revitalizes Hair Follicles

One Month Supply

1-60 mL (2 fl. oz.) Bottle

MINOXIDIL 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (MINOXIDIL) MINOXIDIL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:50383-001-021 BOTTLE in 1 CARTON
160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07473112/24/1996
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIOperations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(50383-001)

 
Hi-Tech Pharmacal Co., Inc.

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Further information

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

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