ROOTLY HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% solution 
TTEM, LLC

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Rootly Hair Regrowth Treatment 2% Minoxidil

Minoxidil 2% w/v

Hair regrowth treatment

USE

to regrow hair on scalp

​For external use only

Flammable: Keep away from fire or flame

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 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 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 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

May be harmful if used when pregnant or breast-feeding.

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).

Alcohol, Propylene Glycol, Purified Water

Questions or comments

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

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ROOTLY HAIR REGROWTH TREATMENT FOR WOMEN 
minoxidil 2% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70150-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70150-004-011 in 1 BOX08/22/2021
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07817608/22/2021
Labeler - TTEM, LLC (079997910)

Revised: 8/2021
 
TTEM, LLC