European Pharmacy & Wellness Products in the USA

Amorolfin beta 50 mg/mL Medicated Nail Lacquer is a topical antifungal medicine by betapharm Arzneimittel GmbH, Germany, used for the treatment of fungal nail infections (onychomycosis).

Each 1 mL contains 50 mg amorolfine (5%), supplied as amorolfine hydrochloride. The medicated lacquer penetrates the nail plate and acts directly against susceptible fungi responsible for nail infections.

Amorolfin beta is intended for fungal infections without involvement of the nail matrix. Comparable authorized 50 mg/mL amorolfine formulations specify use when less than 50% of the nail surface and fewer than three nails are affected.

Key Benefits

• 5% amorolfine antifungal treatment
• Specifically formulated for nail fungus (onychomycosis)
• Targets fungi directly within the affected nail
• Penetrates the nail plate
• Helps inhibit fungal growth
• Convenient once-weekly application
• Suitable for affected fingernails and toenails
• Long-term treatment supports replacement of the infected nail with healthy nail growth
• German pharmacy medicinal product
• Convenient 3 mL treatment kit

Active Ingredient

Amorolfine – 50 mg/mL (5%)

Each 1 mL contains:

• Amorolfine: 50 mg
• Equivalent to Amorolfine Hydrochloride: 55.74 mg

Amorolfine belongs to the morpholine class of antifungal agents and interferes with fungal sterol synthesis, disrupting the fungal cell membrane.

The 50 mg/mL strength and amorolfine-hydrochloride equivalence are confirmed in German product information.

Ingredients

Active Ingredient:
Amorolfine Hydrochloride

Other Ingredients:

• Ammonio Methacrylate Copolymer (Type A)
• Triacetin
• Butyl Acetate
• Ethyl Acetate
• Ethanol

Indication

For the topical treatment of fungal nail infections (onychomycosis) without involvement of the nail matrix.

Treatment should be medically evaluated when the infection is extensive, involves the nail root/matrix, affects numerous nails, or occurs in individuals with conditions that increase the risk of nail complications.

How to Use

Adults

Apply to the affected fingernail or toenail once weekly.

Before the first application:

1. Carefully file down the affected portions of the nail, particularly the nail surface.
2. Clean and degrease the nail surface using an alcohol swab.
3. Apply the medicated lacquer over the entire affected nail surface using the supplied applicator.
4. Allow the lacquer to dry completely.
5. Continue treatment once weekly without interruption until the affected nail has grown out and healthy nail has replaced it.

Do not use a nail file that has been used on an infected nail on healthy nails, as this may spread the fungal infection. Authorized amorolfine instructions emphasize this precaution.

Typical Treatment Duration

Nails grow slowly, so treatment generally requires several months:

• Fingernails: approximately 6 months
• Toenails: approximately 9–12 months

Treatment should continue until the affected portion has completely grown out and the nail has regenerated.

Product Details

Brand: Amorolfin beta
Manufacturer: betapharm Arzneimittel GmbH
Product: Amorolfin beta 50 mg/mL wirkstoffhaltiger Nagellack
Product Type: Antifungal Medicinal Nail Lacquer
Indication: Nail Fungus / Onychomycosis
Active Ingredient: Amorolfine
Strength: 50 mg/mL (5%)
Equivalent: Amorolfine Hydrochloride 55.74 mg/mL
Form: Medicated Nail Lacquer
Route: Topical Nail Application
Volume: 3 mL (0.10 fl oz)
PZN: 15306704
ATC: D01AE16
Country of Origin: Germany
German Status: Pharmacy-Only, Non-Prescription Medicine

The 3 mL package is supplied with application accessories including alcohol swabs, applicators/spatulas, and disposable nail files.

Important Information

• For external use on nails only.
• Do not use if allergic to amorolfine or any ingredient.
• Avoid contact with the eyes, ears, and mucous membranes.
• Do not use the same nail file on infected and healthy nails.
• Not recommended for children and adolescents under 18 years because adequate safety and efficacy data are unavailable.
• Consult a healthcare professional before use during pregnancy or breastfeeding.
• Treatment requires patience and consistent weekly application because healthy nails grow slowly.
• Seek professional medical advice if the infection is extensive, worsening, painful, involves the nail root, or does not improve with treatment.

Possible adverse effects can include nail changes such as discoloration or brittleness and, less commonly, local burning, irritation, or allergic skin reactions.

Storage

Store below 30°C (86°F) and protect from heat.

Keep the bottle tightly closed and upright after use.