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Product NDC Code | 84023-501 | ||||
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Drug Name | Fungal nail liquid |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 313423 | ||||
Application Number | M005 | ||||
Labeler Name | Shenzhen Yangan Technology Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Tolnaftate 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Do not use on children under 2 yearsof age unless directed by a doctorAvoid contact with eyes, ears or mouthIf irritation occurs, discontinue useand consult a doctorIf swallowed, get medical help orconsult a poison control centerimmediately
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water Acetic Acid Sophora Flavescens Lonicerae Japonicae flos Angelicae Glycerin Allantoin Garlic Extract Tea Tree Oi
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.for relief and treatment of pain,soreness,and inflammation from nail fungus. Symptoms: discolored nails brittle nails nail splitting distorted nails
Purpose
Information about the drug product’s indications for use.Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Fungal Nail Liquid Tolnaftate ACETIC ACID SOPHORA FLAVESCENS ROOT LONICERA JAPONICA FLOWER ANGELICA ACUTILOBA ROOT TOLNAFTATE TOLNAFTATE WATER GLYCERIN ALLANTOIN GARLIC TEA TREE OIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label1 label2
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.FUNGAL NAIL LIQUID
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Stop Use And See A Doctor IfYou become pregnant or areplanning to get pregnant whileusing the product.You are allergic to this product(such as itching, rash swelling ofthe lips, eyelids, and shortness ofbreath).
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.If skin becomes red and swollen, or if burning, aching and other forms ofirritation occur, cease using and seek medical advice at once. If you are allergic to this product. Ifsymptoms persist for over 7 days orworsen, consult your physician.Ifyou are pregnant or breast-feeding You become pregnant or areplanning to
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When Using Stop Use And See A Doctor IfYou become pregnant or areplanning to get pregnant whileusing the product.You are allergic to this product(such as itching, rash swelling ofthe lips, eyelids, and shortness ofbreath).
Storage and handling
Information about safe storage and handling of the drug product.Store in a cool and dry place.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API