AMOROPHEN HYDROCHLORIDE LINIMENT- amorolfine hydrochloride liquid

Amorophen hydrochloride liniment by

Drug Labeling and Warnings

Amorophen hydrochloride liniment by is a Otc medication manufactured, distributed, or labeled by ZheJiang Longmed Medical Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

amorolfine hydrochloride 5%

PURPOSE

antifungal

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN SECTION

INDICATIONS & USAGE

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

WARNINGS

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

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

Shelf life 3-Year

INACTIVE INGREDIENT

WATER
alcohol
Sorbitol
propylene glycol
root of Dahurian angelica
keratin
tolnaftate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMOROPHEN HYDROCHLORIDE LINIMENT 
amorolfine hydrochloride liquid

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

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

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

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

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

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

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