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Product NDC Code | 84539-001 | ||||
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Drug Name | Johnson foam for men |
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Type | Brand | ||||
Pharm Class | 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | AEROSOL, FOAM | ||||
Application Number | M032 | ||||
Labeler Name | JOHNSON BIOPHARMACEUTICAL INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.MINOXIDIL 5% FINASTERIDE 0.1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Fight primary cause of hair loss in men. Anti hair loss to help increase hair densityand volume.
Spl product data elements
Usually a list of ingredients in a drug product.JOHNSON FOAM FOR MEN MINOXIDIL FINASTERIDE FINASTERIDE EDETATE DISODIUM ALCOHOL MINOXIDIL MINOXIDIL GLYCERIN WATER COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN (1000 MW) UBIQUINOL BIOTIN ZINC PIDOLATE BUTYLATED HYDROXYTOLUENE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) LEVOMENTHOL POLOXAMER 407 POLYSORBATE 80
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label3 label4
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of childrenIfswallowed,get medical help or contact a PoisonControlCenter rightaway
Storage and handling
Information about safe storage and handling of the drug product.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℃)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.For external use only For use by men only. Extremely Flammable Avoid fire, flame, or smoking during and immediatelyfollowing application.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API