THICK HEAD EXTRA STRENGTH FOR MEN 5 MINOXIDIL TOPICAL- minoxidil spray 
PROFECTUS BEAUTY, LLC

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THICK HEAD Extra Strength for Men 5% Minoxidil Topical Solution

Drug Facts

Active ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment

Use

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

Warnings

For external use only. For use by men only.

Flammable:Keep away from fire or flame

Do not use if:

• you are a woman • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline • you have no family history of hair loss • your hair loss is sudden and/or patchy • you do not know the reason for your hair loss • you are under 18 years of age. Do not use on babies and children • your scalp is red, inflamed, irritated or painful • you use other medicines on the 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 the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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 and ask a 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

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

• prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist • apply one mL with spray (6 sprays) 2 times a daydirectly 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 18-45 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 20º to 25ºC (68º to 77ºF).

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

1-(800)-555-5163
Visit Website at www.thickhead.com

Package Labeling:

Outer Package2Inner Package2

THICK HEAD EXTRA STRENGTH FOR MEN 5 MINOXIDIL TOPICAL 
minoxidil spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70550-602
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
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70550-602-011 in 1 BOX10/02/2023
160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623910/02/2023
Labeler - PROFECTUS BEAUTY, LLC (118310694)

Revised: 9/2023
Document Id: 062add1a-666d-1441-e063-6294a90a5ed2
Set id: 8d58d0d3-0427-d045-e053-2995a90ac8e7
Version: 2
Effective Time: 20230925
 
PROFECTUS BEAUTY, LLC