HIMS- minoxidil 5% liquid

hims by

Drug Labeling and Warnings

hims by is a Otc medication manufactured, distributed, or labeled by Clubroom, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 5% w/v

PURPOSE

Hair regrowth treatment for men

INDICATIONS & USAGE

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

WARNINGS

For external use only

For use by men only

Flammable: Keep away from fire or flame

Do not use if
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. Minoxidil Topical Solution, 5% 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. 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 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.

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.

DOSAGE & ADMINISTRATION

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

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 aged 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 controlled room temperature 20º to 25ºC (68º to 77ºF).

INACTIVE INGREDIENT

alcohol, propylene glycol, purified water

QUESTIONS

Questions or Comments: Call toll-free 1 (800) 368-0038 or Visit Website at www.forhims.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HIMS 
minoxidil 5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71730-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	50 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71730-042-08	1 in 1 BOX	11/18/2017
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	ANDA075518	11/01/2017

Labeler - Clubroom, Inc. (080696472)