Amorophen hydrochloride liniment

Manufacturer
ZheJiang Longmed Medical Technology Co., Ltd.
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:50:44

Label at a glance#

ProductAmorophen hydrochloride liniment
Active ingredientAMOROLFINE HYDROCHLORIDE
Label structure9 sections

Storage and handling

Shelf life 3-Year

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

amorolfine hydrochloride 5%

OTC - PURPOSE SECTION

antifungal

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN SECTION

INDICATIONS & USAGE SECTION

Thisproduct isdermatological drugcategory,over-the-counter drugs.
This product is indicated for the treatment of nail (includingtoenail) infections caused by susceptible fungi.

WARNINGS SECTION

1. The first time you use this product, please consult aprofessional doctor and confirm the diagnosis of nail fungalinfection suitable for this product.
2. Patients with extensive fungal infections, such as those withmore than two fingernails (or toenails) affected or a singletoenail infection covering more than half of the nail area, requirecomprehensive treatment. Consultation with a specialist isrecommended before using this product.
3.Please read the instructions carefully before usingthisproduct, and use it in strict accordance with the instructions.
4. This product should not be inhaled and should avoid contactwith mucous membranes (such as mouth, nose) and skin folds.
5. lf the liniment accidentally gets into the eyes or ears, rinsewith water immediately, and immediately go to the nearesthospital to consult a doctor or pharmacist.
6. lf you take this product by mistake, go to the nearest hospitalimmediately to consult a doctor or pharmacist.
7. Lactating women should avoid using this product.
8. lt is not recommended for children due to the lack of relevantclinical research data.

DOSAGE & ADMINISTRATION SECTION

1. File down (toenails)
2. Clean your nails
3. Remove the liniment from the vial4. Apply liniment
5. Drying
6. Cleaning the Medicine Shovel (Medicine spatula)
7. Before using this product for the second time, remove the oldointment with a medical cotton swab.
Please read the instructions carefully before using this product,and use it in strict accordance with the instructions.

STORAGE AND HANDLING SECTION

Shelf life 3-Year

INACTIVE INGREDIENT SECTION

WATER
alcohol
Sorbitol
propylene glycol
root of Dahurian angelica
keratin
tolnaftate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84534-002AMOROPHEN HYDROCHLORIDE LINIMENT (AMOROLFINE HYDROCHLORIDE) LIQUID [ZHEJIANG LONGMED MEDICAL TECHNOLOGY CO., LTD.]1Unmatched20241101_25c097cf-481a-d59a-e063-6294a90a9a39.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84534-00284534-002-01, 84534-002-02, 84534-002-03, 84534-002-04, 84534-002-05, 84534-002-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
397c06e7-c554-7fc7-e063-6294a90a955c25c097cf-481a-d59a-e063-6294a90a9a392025-07-09WarningsExact identifier
spl set id: 25c097cf-481a-d59a-e063-6294a90a9a39

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.