Otc - Active Ingredient
MINOXIDIL 5%
FINASTERIDE 0.1%
Johnson Foam
FDA Label NDC 84539-001
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 (NDC 84539-001). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Fight primary cause of hair loss in men. Anti hair loss
to help increase hair densityand volume.
Otc - Keep Out Of Reach Of Children
Keep out of reach of childrenIfswallowed,get medical help or contact a PoisonControlCenter rightaway
Indications & Usage
Fight primary cause of hair loss in men.Anti hair lossto help increase hair density and volume
do not apply on other parts of the body.
avoid contactwith eyes.In case of accidental contactrinse eyes with large amounts of cool tap water.
some people have experienced changes in hair colorand/or texture
Warnings
For external use only
For use by men only.
Extremely Flammable
Avoid fire, flame, or smoking during and immediatelyfollowing application.
Dosage & Administration
1.PREP HANDSWITH COLD WATERRinse Your Fingers In Cold WaterAnd DryThem.note:Foam Will MeltOn Contact With Warm Surfaces.
2.OPEN CHILDRESISTANT CAP
Be Sure To Align Arrow On The capWith Arrow On Blue Ring. Tilt CapBack And Pull Off.
3.DISPENSEVERTICALLYONTOACOLD SURFACE
Hold The Can Straight UpsideDown.lf You Hold Thecan At AnAngle, Foam May Not DispenseProperly.Press Nozzle To DispenseHalfACapful Of Foam Onto ColdSurface(e.g.dish.or Cold Hands).
4.APPLYTOSCALP.NOT HAIR
Part Your Hair To Expose Hair LossArea.Massage Foam Into ScalpNot Hair, Repeat UntilAll HairLossAreas Have Been Covered.
5.CLOSE CAP AND WASHHANDSsnap cap back into place be surearrows do not line up, so cap remainschild resistant, wash hands and anysurface thoroughly afteruse
Storage And Handling
Store at controlledroom temperature20 ℃ to 25 ℃68°to 77 F).Contentsunder pressure.Do not puncture orincinerate container. Do not expose toheat or store at temperatures above120F(49℃)
Inactive Ingredient
ALCOHOL
GLYCERIN
WHATER
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
HYDROLYZED KERATIN
UBIQUINOL
BIOTIN
ZINC PIDOLATE
BUTYLATED HYDROXYTOLUENE
EDETATE DISODIUM
LEVOMENTHOL
Poloxzam
POLYSORBATE 80
Package Label.Principal Display Panel
Label (Label1)
Label2 (Label2)
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