SPL v1
SPL
SPL Set ID 460a4533-10ca-195a-e063-6294a90a3097
Route
TOPICAL
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Finasteride (0.1 g) Minoxidil (5 g)
Inactive Ingredients
1,4-butanediol Cocamidopropyl Betaine Dimethylsilanol Hyaluronate Sodium Chloride Zinc Pca Water Alcohol Menthol, (+)- Sodium Laureth-5 Carboxylate Sodium Cocoyl Glycinate Disodium Cocoyl Glutamate Sorbitol Poloxamer 407 Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-16
Description

Active Ingredients:Minoxidil (5%),Finasteride(0.1%)

Medication Information

Warnings and Precautions

Warnings:

for external use only.for use by men only.extremelyflammable.avoid fire, flame, or smoking duringand immediately following application.

Indications and Usage

1. PREP HANDS WITH

COLD WATER

Rinse your fingers in cold

water and dry them.

Note: Foam will melt on

contact with warm surfaces

2.OPEN THE CAP

Tilt cap back and pull off.

3.DISPENSE VERTICALLY

ONTO A COLD SURFACE

Press nozzle to dispense half acapful of foam onto cold

surface(e.g.dish.or cold hands)

4.APPLY TO SCALP, NOT HAIR

Part your hair to expose hair lossarea.Massage foam into scalp, notHair, repeat until all hair loss areashave been covered.

5.CLOSE CAP AND

WASH HANDS

Snap cap back into place,

wash hands and any surface

thoroughly after use.

Dosage and Administration

Take an appropriate amount and place it in the palm

Description

Active Ingredients:Minoxidil (5%),Finasteride(0.1%)

Section 50565-1

Keep out of reach of childrerIf swallowed, get medical help orcontact a Poison Control Centerright away.

Section 51727-6

Butanediol, Water, Ethanol, Menthol.Pca Zinc, Sodium LaurethCarboxylate, Ppg-10 Sorbitol,Sodium Cocoyl Glycinate, DisodiumCocoyl Glutamate, Sodium Chloride,Cocoamidopropyl Betaine,Panthenol, DimethylsilanolHyaluronic Acid, Poloxamer 407

Section 51945-4

Section 55105-1

Purpose:Fight primary cause of hair loss inmen. Anti-hair loss to helpincrease hair density and volume.

Section 55106-9

Active Ingredients:Minoxidil (5%),Finasteride(0.1%)

Structured Label Content

Indications and Usage (34067-9)

1. PREP HANDS WITH

COLD WATER

Rinse your fingers in cold

water and dry them.

Note: Foam will melt on

contact with warm surfaces

2.OPEN THE CAP

Tilt cap back and pull off.

3.DISPENSE VERTICALLY

ONTO A COLD SURFACE

Press nozzle to dispense half acapful of foam onto cold

surface(e.g.dish.or cold hands)

4.APPLY TO SCALP, NOT HAIR

Part your hair to expose hair lossarea.Massage foam into scalp, notHair, repeat until all hair loss areashave been covered.

5.CLOSE CAP AND

WASH HANDS

Snap cap back into place,

wash hands and any surface

thoroughly after use.

Dosage and Administration (34068-7)

Take an appropriate amount and place it in the palm

Warnings and Precautions (34071-1)

Warnings:

for external use only.for use by men only.extremelyflammable.avoid fire, flame, or smoking duringand immediately following application.

Section 50565-1 (50565-1)

Keep out of reach of childrerIf swallowed, get medical help orcontact a Poison Control Centerright away.

Section 51727-6 (51727-6)

Butanediol, Water, Ethanol, Menthol.Pca Zinc, Sodium LaurethCarboxylate, Ppg-10 Sorbitol,Sodium Cocoyl Glycinate, DisodiumCocoyl Glutamate, Sodium Chloride,Cocoamidopropyl Betaine,Panthenol, DimethylsilanolHyaluronic Acid, Poloxamer 407

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:Fight primary cause of hair loss inmen. Anti-hair loss to helpincrease hair density and volume.

Section 55106-9 (55106-9)

Active Ingredients:Minoxidil (5%),Finasteride(0.1%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:43.120615 · Updated: 2026-03-14T23:11:27.729526