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Nail fungus treatment - Medication Information

Product NDC Code 84257-101
Drug Name

Nail fungus treatment

Type Brand
Active Ingredients
Salicylic acid 6.6 g/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 2679295
Application Number 505G(a)(3)
Labeler Name Guangzhou Maitelin Information Technology Co., Ltd.
Packages
Package NDC Code Description
84257-101-01 20 ml in 1 bottle (84257-101-01)
84257-101-02 25 ml in 1 bottle (84257-101-02)
84257-101-03 30 ml in 1 bottle (84257-101-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Salicylic Acid 6.6%

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.
Read all package directions and warningsbefore use. Before the first use, soak the diseasednail in warm water to soften it. Wash anddry thoroughly, gently polish the diseasednail with a nail file to make it thinner andremove dirt, taking care not to hurt the nailbed. Then apply the liquid. Do not scrub within 1 hour after use. Apply the product twice a day. (In themorning and night) After the first application, every 2-3 daysfile the surface of the diseased nail andcontinue regular usage.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
AQUA GARDEN BALSAM FLOWER PHRYMA LEPTOSTACHYA WHOLE STEMONAE RADIX ANGELICA DAHURICA ROOT PSEUDOLARIXAMABILIS BARK ARTEMISIA ARGYI LEAF ACETIC ACID POLYOXYL 35 CASTOR OIL

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.
Effective for fighting against fungalcausingbacteria of fingernails or toenails: thick orridged, discolored, gel manicure/pedicuredamage, aging & brittle.

Purpose

Information about the drug product’s indications for use.
Anti-fungal

Spl product data elements

Usually a list of ingredients in a drug product.
Nail Fungus Treatment Salicylic Acid PHRYMA LEPTOSTACHYA WHOLE ANGELICA DAHURICA ROOT PSEUDOLARIX AMABILIS BARK SALICYLIC ACID SALICYLIC ACID WATER STEMONA SESSILIFOLIA ROOT IMPATIENS BALSAMINA FLOWER ARTEMISIA ARGYI LEAF ACETIC ACID POLYOXYL 35 CASTOR 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.
label 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.
Nail Fungus Treatment

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.
Don't use on children under 2 years ofage unless directed by a doctor. Don't use it on damaged skin; otherwise, your damaged skin may be painful. Don't use this product, if you are pregnantor nursing.

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. If swal-lowed, get medical help or contact a poisoncontrol center right away.

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.
Stop use and consult a doctor/healthcareprofessional if irritation or symptom-sworsen.

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.
Avoid eye contact, if contact occurs, rinsethoroughly with water.

Storage and handling

Information about safe storage and handling of the drug product.
Store at room temperature 15°-30°C(59°-86°F) away from direct sunlight.Prevent freezing.

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