Label: AMOROPHEN HYDROCHLORIDE LINIMENT- amorolfine hydrochloride liquid
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NDC Code(s):
84534-002-01,
84534-002-02,
84534-002-03,
84534-002-04, view more84534-002-05, 84534-002-06
- Packager: ZheJiang Longmed Medical Technology Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 31, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMOROPHEN HYDROCHLORIDE LINIMENT
amorolfine hydrochloride liquidProduct 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)
