ROOTLY EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN- minoxidil 5% solution

Rootly Extra Strength Hair Regrowth Treatment for Men by

Drug Labeling and Warnings

Rootly Extra Strength Hair Regrowth Treatment for Men by is a Otc medication manufactured, distributed, or labeled by TTEM, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 5% w/v

PURPOSE

Hair regrowth treatment for men

USE

to regrow hair on the top of the scalp

WARNINGS

For external use only.

Flammable: Keep away from fire or flame.

DO NOT USE

Do not use if

• You are a woman
• Your degree of hair loss is different than that shown on 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 or children.
• Your scalp is red, inflammed, infected, irritated, or painful
• You use other medicines on your scalp

ASK DOCTOR

Ask a doctor before use if you have heart disease

WHEN USING

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 change in hair color and/or texture. It takes time to regrow hair. For some men, 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 all men.

STOP USE

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

PREGNANCY OR BREAST FEEDING

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.

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 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 regrowth than 2% minoxidil topical solution

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

INACTIVE INGREDIENT

lcohol, Propylene Glycol, Purified Water

QUESTIONS

Questions or comments

Call toll-free 1-800-681-0241 or visit hellorootly.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROOTLY EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN 
minoxidil 5% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70150-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70150-005-01	1 in 1 BOX	08/24/2021
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	ANDA076239	08/24/2021

Labeler - TTEM, LLC (079997910)