GROFULLY MENS EXTRA STRENGTH HAIR REGROWTH TREATMENT- minoxidil 5% solution 
TTEM, Inc

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GROFULLY 5% Minoxidil Topical Solution

Minoxidil 5% w/v

Hair regrowth treatment for men

USE

to regrow hair on the top of the scalp (vertex only, see picture on side on carton)

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).

Alcohol, Propylene Glycol, Purified Water

Questions or comments

Call toll-free 1-800-559-7691

or visit grofully.com

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GROFULLY MENS EXTRA STRENGTH HAIR REGROWTH TREATMENT 
minoxidil 5% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70150-007
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)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70150-007-011 in 1 BOX01/24/2022
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623901/24/2022
Labeler - TTEM, Inc (079997910)

Revised: 1/2022
Document Id: d65f3429-c65e-e688-e053-2995a90ab4df
Set id: d65f3429-c65d-e688-e053-2995a90ab4df
Version: 1
Effective Time: 20220124
 
TTEM, Inc