Drug labels

JOHNSON FOAM

MINOXIDIL · JOHNSON BIOPHARMACEUTICAL INC. · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
1d44a75c-c940-680c-e063-6394a90a5839
ID
581d5ca7-ed15-8a92-e063-6294a90aa8a8
Effective time
20260802
Version
8
SPL product data elements

JOHNSON FOAM MINOXIDIL FINASTERIDE FINASTERIDE MINOXIDIL MINOXIDIL EDETATE DISODIUM ALCOHOL GLYCERIN WATER UBIQUINOL ZINC PIDOLATE BUTYLATED HYDROXYTOLUENE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LEVOMENTHOL POLOXAMER 407 POLYSORBATE 80

Active ingredient
MINOXIDIL 5% FINASTERIDE 0.1%
Purpose
Fight primary cause of hair loss in men. Anti hair loss to help increase hair densityand volume.
Keep out of reach of children
Keep out of reach of childrenIfswallowed,get medical help or contact a PoisonControlCenter rightaway
Indications and 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 and 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) UBIQUINOL ZINC PIDOLATE BUTYLATED HYDROXYTOLUENE EDETATE DISODIUM LEVOMENTHOL Poloxzam POLYSORBATE 80

Package label principal display panel
label
Harmonized identifiers (openFDA)
Application number
M032
Brand name
JOHNSON FOAM
Generic name
MINOXIDIL
Manufacturer name
JOHNSON BIOPHARMACEUTICAL INC.
Product NDC
84539-001
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
FINASTERIDE, MINOXIDIL
SPL ID
581d5ca7-ed15-8a92-e063-6294a90aa8a8
SPL set ID
1d44a75c-c940-680c-e063-6394a90a5839
Package NDC
84539-001-01
Is original packager
true
Nui
N0000175836, N0000000126, N0000175379, N0000175564
Pharm class epc
5-alpha Reductase Inhibitor [EPC], Arteriolar Vasodilator [EPC]
Pharm class moa
5-alpha Reductase Inhibitors [MoA]
Pharm class pe
Arteriolar Vasodilation [PE]
UNII
57GNO57U7G, 5965120SH1
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.