JOHNSON FOAM- minoxidil aerosol, foam

JOHNSON FOAM by

Drug Labeling and Warnings

JOHNSON FOAM by is a Otc medication manufactured, distributed, or labeled by JOHNSON BIOPHARMACEUTICAL INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 & 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)
UBIQUINOL
ZINC PIDOLATE
BUTYLATED HYDROXYTOLUENE
EDETATE DISODIUM
LEVOMENTHOL
Poloxzam
POLYSORBATE 80

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JOHNSON FOAM 
minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84539-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)	FINASTERIDE	0.1 g  in 100 g
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
UBIQUINOL (UNII: M9NL0C577Y)
ZINC PIDOLATE (UNII: C32PQ86DH4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LEVOMENTHOL (UNII: BZ1R15MTK7)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84539-001-01	90 g in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	07/15/2024

Labeler - JOHNSON BIOPHARMACEUTICAL INC. (132195896)

Establishment
Name	Address	ID/FEI	Business Operations
JOHNSON BIOPHARMACEUTICAL INC.		132195896	manufacture(84539-001)