KEEPS- minoxidil 5% liquid

Keeps by

Drug Labeling and Warnings

Keeps by is a Otc medication manufactured, distributed, or labeled by Thirty Madison Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 5.0% 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, 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 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

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?
1-833-745-3377

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KEEPS 
minoxidil 5% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71713-095
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
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71713-095-10	3 in 1 BOX	11/15/2017
1		60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074588	11/15/2017

Labeler - Thirty Madison Inc (080774087)