JOHNSON FOAM PRO- finasteride foam with 5% minoxidil aerosol, foam

JOHNSON FOAM PRO by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

JOHNSON FOAM PRO

ACTIVE INGREDIENT

MINOXIDIL 5%
FINASTERIDE 0.25%

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.

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.

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.

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JOHNSON FOAM PRO 
finasteride foam with 5% minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84539-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)	FINASTERIDE	0.25 g  in 100 g
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84539-002-01	90 g in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	11/21/2024

Labeler - JOHNSON BIOPHARMACEUTICAL INC. (132195896)

Establishment
Name	Address	ID/FEI	Business Operations
JOHNSON BIOPHARMACEUTICAL INC.		132195896	manufacture(84539-002)