SOLUTION- minoxidil solution

Solution by

Drug Labeling and Warnings

Solution by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest Mfg, Ei LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Minoxidil 2% w/v..........................................................................................................Hair regrowth treatment

Use

To regrow hair on the scalp (vertex only, see picture on side of carton)

WarningsFor external use only.

Flammable: Keep away from fire or flame

Do not use if:

• Your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
• You have no family history of hair loss
• Your hair loss is sudden and/or patchy
• Your hair loss is associated with childbirth
• 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

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 hands or feet swell
• Scalp irritation or 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.

PURPOSE

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
• In clinical studies of mostly white women aged 18-49 years wiht mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it for 8 months (7% had moderate regrowth, 33% had minimal regrowth)
• Store at controlled room temperature 20​o​ to 25​o​C (68​o​ to 77​o​F). Keep tightly closed.

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 you hair regrowth, or hair loss will begin again

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Label

INGREDIENTS AND APPEARANCE

SOLUTION 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-2173
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	0.02 g  in 1 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: 0363-2173-02	1 in 1 PACKAGE	08/08/2014
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	ANDA078176	08/08/2014

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	manufacture(0363-2173)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	label(0363-2173)