ROOTLY HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% solution

Rootly Hair Regrowth Treatment for Women by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 2% w/v

PURPOSE

Hair regrowth treatment

USE

to regrow hair on scalp

WARNINGS

​For external use only

Flammable: Keep away from fire or flame

DO NOT USE

Do not use if

• 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. You may need to use this product 2 times a day for at least 4 months before you see results.
• The amount of hair regrow is different for each person. This product will not work for everyone.

STOP USE

Stop use and ask a doctor if

• Chest pain, rapid heartbeat, faintness, or dizziness occurs
• Sudden, unexplained weight gain occurs
• Your hand 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 1 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.
• In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solutions was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth: 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth: 33% had minimal regrowth).
• Store at controlled room temperature 68 o - 77 oF (20 o - 25 oC).

INACTIVE INGREDIENT

Alcohol, 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 HAIR REGROWTH TREATMENT FOR WOMEN 
minoxidil 2% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70150-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	2 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70150-004-01	1 in 1 BOX	08/22/2021
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	ANDA078176	08/22/2021

Labeler - TTEM, LLC (079997910)