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JOHNSON FOAM PRO
Johnson Foam Pro
FDA Label NDC 84539-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Johnson Biopharmaceutical Inc. for the product Johnson Foam Pro (NDC 84539-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
MINOXIDIL 5%
FINASTERIDE 0.25%
Otc - Purpose
Fight primarycause ofhalr loss in men.Antihalrlosstohelpincreasehairdenslty andvolume.
Indications & Usage
Fight primarycause ofhalr loss in men.Antihalrlosstohelpincreasehairdenslty andvolume.
Warnings
Forexternaluse only.
Foruse by men only.
Extremely Flammable.
Avoid fire, flame, or smoking during andimmedlately following application.
Otc - Do Not Use
you have no famlly hlstory of halrloss.
you rhalrloss is sudden and/or patchy.
you do not know the reason for your halr loss.
you are under 18 years of age.
Do not useonbables or chikdren.
yourscalp is red, inflamed,infected,rritated, or painful.
you use other medicines on the scalp.
Otc - When Using
do not apply on other parts of the body.
avold contact with eyes. In case ofaccldental contact.rinse eyes with large amounts ofcooltap water.
some people have experienced changes in halr colorandortexture.
Otc - Stop Use
chest pain, rapld heartbeat, faintness,ordlzziness occurs.
sudden,unexplained weight gain occurs.
your hands or feet swell.
scalp irritation or redness occurs.
umwanted facialhalrgrowth occurs.
you donot see halrregrowthin 4 months.
Otc - Keep Out Of Reach Of Children
If swallowed,getmedical help or contacta Poison
Control Center right away.
Dosage & Administration
1.PREP HANDSWITH COLD WATERRinse Your Fingers inCald WaterAnd Doy Them note: Foam Wll MeltOn Contat WithWarmSurfacs.
2.OPENCHILD RESISTANTCAPBe Sure To Align Arrow On The CapWith Arrow On Blue Ring.Tit capBadkAnd Pull ot.
3.DISPENSEVERTICALLYONTOACOLDSURFACEHoldThe Can Staght UpsideDown.if You Hdd ThecanAtAnAngle, Foam May Nat DispansePoperhy, PressNozzie To Dispe nseHalfACapiu OfFoam Onto CaldSuface(e gdshorCod Hands).
4.APPLYTOSCALP, NOTHAIRPart Your Hair To Expose HairLossAra. Massage Foamhno Sedp.NotHair, Repeat UnslAllHar LossAras Have Been Covered.
5.CLOSE CAP AND WASHHANDSsn ap cap back into plaoe be surearows do notline up,socapmmanschid resistant, wash hands andamysurace thoroughly a feruse .
Inactive Ingredient
ALCOHOL
GLYCERIN
WHATER
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
UBIQUINOL
ZINC PIDOLATE
BUTYLATED HYDROXYTOLUENE
EDETATE DISODIUM
LEVOMENTHOL
Poloxzam
POLYSORBATE 80
Package Label.Principal Display Panel
Label3 (Label3)
Label4 (Label4)
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