Minoxidil by Hi-Tech Pharmacal Co., Inc. MINOXIDIL solution

Minoxidil by

Drug Labeling and Warnings

Minoxidil by is a Otc medication manufactured, distributed, or labeled by Hi-Tech Pharmacal Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MINOXIDIL 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50383-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50383-001-02	1 in 1 CARTON	12/24/1996
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	ANDA074731	12/24/1996

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE(50383-001)