Amorophen hydrochloride liniment

Drug Details [pdf]

AMOROPHEN HYDROCHLORIDE LINIMENT- amorolfine hydrochloride liquid
ZheJiang Longmed Medical Technology Co., Ltd.

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Amorophen hydrochloride liniment

amorolfine hydrochloride 5%

antifungal

KEEP OUT OF REACH OF CHILDREN SECTION

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

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.

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.

Shelf life 3-Year

WATER
alcohol
Sorbitol
propylene glycol
root of Dahurian angelica
keratin
tolnaftate

label

AMOROPHEN HYDROCHLORIDE LINIMENT
amorolfine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84534-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMOROLFINE HYDROCHLORIDE (UNII: 741YH7379H) (AMOROLFINE - UNII:AB0BHP2FH0)	AMOROLFINE HYDROCHLORIDE	5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
KERATIN, TYPE I CYTOSKELETAL 18 (UNII: ZS6J3E8DAS)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TOLNAFTATE (UNII: 06KB629TKV)
SORBITOL (UNII: 506T60A25R)
ANGELICA ACUTILOBA WHOLE (UNII: 61617L0028)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 84534-002-01	1.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024	07/09/2025
2	NDC: 84534-002-02	2 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024	07/09/2025
3	NDC: 84534-002-03	2.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024	07/09/2025
4	NDC: 84534-002-04	3 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024	07/09/2025
5	NDC: 84534-002-05	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024	07/09/2025
6	NDC: 84534-002-06	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2024	07/09/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	10/31/2024	07/09/2025

Labeler - ZheJiang Longmed Medical Technology Co., Ltd. (554468373)

Name	Address	ID/FEI	Business Operations
Establishment
ZheJiang Longmed Medical Technology Co., Ltd.		554468373	manufacture(84534-002)

Revised: 7/2025

Document Id: 397c06e7-c554-7fc7-e063-6294a90a955c

Set id: 25c097cf-481a-d59a-e063-6294a90a9a39

Version: 2

Effective Time: 20250709

ZheJi

Amorophen hydrochloride liniment

Amorophen hydrochloride liniment by

Drug Labeling and Warnings

Drug Details [pdf]

Amorophen hydrochloride liniment