ROOTVIVE MENS HAIR REGROWTH TREATMENT EXTRA STRENGTH MINOXIDIL- minoxidil solution

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

Use

to regrow hair on the top of 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, infected, irritated or painful you use other medicine 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 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 grow 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 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

Keep out of the reach of children.

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

May be harmful if used when pregnant or breast-feeding

Directions

apply one mL with dropper 2 times a daydirectly 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 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 growth than 2% minoxidil topical solution  store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

(346) 202-2858
Visit Website at www.shoprootvive.com

Package Labeling:

INGREDIENTS AND APPEARANCE

ROOTVIVE MENS HAIR REGROWTH TREATMENT EXTRA STRENGTH MINOXIDIL 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87663-962
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
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87663-962-00	1 in 1 BOX	04/17/2026
1		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076239	04/17/2026

Labeler - TrueRoot Labs LLC (142888871)

Registrant - Pure Source, LLC (080354456)