MENS COMBACK HAIR REGROWTH TREATMENT EXTRA STRENGTH UNSCENTED- minoxidil liquid 
Combback International LLC

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Men's ComBack HAIR REGROWTH TREATMENT EXTRA STRENGTH UNSCENTED

Men's ComBack HAIR REGROWTH TREATMENT EXTRA STRENGTH UNSCENTED


Active Ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

Use

on the top of the scalp (vertex only, see picture on side of the 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, infected, 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 breastfeeding.


Keep out of reach of children.

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 with mostly white men aged 19-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth that 2% minoxidil topical solution
  • store at USP Controlled Room Temperature 20º to 25ºC(68º to 77ºF)

Inactive Ingredients

alcohol, propylene glycol, purified water

Questions?

Call 1.855.600.HAIR 1.855.600.4247 or see us at: www.COMBBACK.com

Men's ComBack HAIR FOR LIFE

HAIR REGROWTH TREATMENT
5% MINOXIDIL TOPICAL SOLUTION
EXTRA STRENGTH

This Package Contains:

  • One 60 mL (2 fl oz) Bottle of Men’s COMBBACK™ Extra Strength (one month supply)
  • One child-resistant dropper applicator
  • Information leaflet with complete directions on how to use and obtain best results

FOR BEST RESULTS  Apply Directly to Scalp Twice Daily

Distributed by:
COMBBACK™ INTERNATIONAL LLC.
Eatontown N.J. 07724
1.855.600.HAIR 1.855.600.4247
www.COMBBACK.com

HAIR REGROWTH TREATMENT
5% MINOXIDIL TOPICAL SOLUTION
EXTRA STRENGTH

Men’s COMBBACK™ Extra Strength is for men who have a general thinning of hair on the top of the scalp (vertex only, as shown below). Not intended for frontal baldness or a receding hairline.

Men’s COMBBACK™ Extra Strength has been shown to regrow hair in men with the following degrees of thinning hair or hair loss.

Vertex  Vertex  Vertex

If men have more hair loss or hair loss in a place different then shown above, Men’s COMBBACK™ Extra Strength may not work.

Men's ComBack HAIR FOR LIFE

HAIR REGROWTH TREATMENT
5% MINOXIDIL TOPICAL SOLUTION
EXTRA STRENGTH

UNSCENTED

Clinically Proven to Help Regrow Hair

Reactivates Hair Follicles to Stimulate Regrowth

Not For Use By Women

One Month Supply
1-60 mL (2 fl oz) Bottle

Men's ComBack HAIR REGROWTH TREATMENT EXTRA STRENGTH UNSCENTED 2oz/60ml (58852-000-02)

Bottle LabelBox Label

MENS COMBACK HAIR REGROWTH TREATMENT EXTRA STRENGTH UNSCENTED 
minoxidil liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58852-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58852-000-021 in 1 CARTON
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623906/06/201301/05/2016
Labeler - Combback International LLC (078820471)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source Inc.969241041manufacture(58852-000)

Revised: 1/2016
 
Combback International LLC