Johnson Foam

Johnson Foam
SPL v6
SPL
SPL Set ID 1d44a75c-c940-680c-e063-6394a90a5839
Route
TOPICAL
Published
Effective Date 2024-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Finasteride (0.1 g) Minoxidil (5 g)
Inactive Ingredients
Edetate Disodium Alcohol Glycerin Water Ubiquinol Zinc Pidolate Butylated Hydroxytoluene Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Levomenthol Poloxamer 407 Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-15

Description

MINOXIDIL 5% FINASTERIDE 0.1%


Medication Information

Warnings and Precautions

For external use only

For use by men only.

Extremely Flammable

Avoid fire, flame, or smoking during and immediatelyfollowing application.

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

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

Description

MINOXIDIL 5% FINASTERIDE 0.1%

Section 44425-7

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℃)

Section 50565-1

Keep out of reach of childrenIfswallowed,get medical help or contact a PoisonControlCenter rightaway

Section 51727-6

ALCOHOL

GLYCERIN

WHATER

CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)

UBIQUINOL

ZINC PIDOLATE

BUTYLATED HYDROXYTOLUENE

EDETATE DISODIUM

LEVOMENTHOL

Poloxzam

POLYSORBATE 80

Section 51945-4

Section 55105-1

Fight primary cause of hair loss in men. Anti hair loss

to help increase hair densityand volume.

Section 55106-9

MINOXIDIL 5%

FINASTERIDE 0.1%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only

For use by men only.

Extremely Flammable

Avoid fire, flame, or smoking during and immediatelyfollowing application.

Section 44425-7 (44425-7)

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℃)

Section 50565-1 (50565-1)

Keep out of reach of childrenIfswallowed,get medical help or contact a PoisonControlCenter rightaway

Section 51727-6 (51727-6)

ALCOHOL

GLYCERIN

WHATER

CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)

UBIQUINOL

ZINC PIDOLATE

BUTYLATED HYDROXYTOLUENE

EDETATE DISODIUM

LEVOMENTHOL

Poloxzam

POLYSORBATE 80

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Fight primary cause of hair loss in men. Anti hair loss

to help increase hair densityand volume.

Section 55106-9 (55106-9)

MINOXIDIL 5%

FINASTERIDE 0.1%


Advanced Ingredient Data


Raw Label Data

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