FDA Label for Amorophen Hydrochloride Liniment
View Indications, Usage & Precautions
Amorophen Hydrochloride Liniment Product Label
The following document was submitted to the FDA by the labeler of this product Zhejiang Longmed Medical Technology Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
amorolfine hydrochloride 5%
Otc - Purpose
antifungal
Otc - 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
Package Label.Principal Display Panel
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