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

----------

Rootly Extra Strength Hair Regrowth Treatment for Men

Minoxidil 5% w/v

Hair regrowth treatment for men

USE

to regrow hair on the top of the scalp

For external use only.

Flammable: Keep away from fire or flame.

Do not use if

Ask a doctor before use if you have heart disease

When using this product

Stop use and ask doctor if

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 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).

lcohol, Propylene Glycol, Purified Water

Questions or comments

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

box

ROOTLY EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN 
minoxidil 5% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70150-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70150-005-011 in 1 BOX08/24/2021
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623908/24/2021
Labeler - TTEM, LLC (079997910)

Revised: 1/2023
Document Id: f28bbeee-ee5a-4aba-e053-2995a90ade84
Set id: ca58449e-6641-4225-e053-2995a90a5a41
Version: 2
Effective Time: 20230118
 
TTEM, LLC