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Wart remover - Medication Information

Product NDC Code 83299-010
Drug Name

Wart remover

Type Generic
Active Ingredients
Salicylic acid 12 mg/100ml
Route TOPICAL
Dosage Form LIQUID
Application Number M028
Labeler Name Consilii LLC
Packages
Package NDC Code Description
83299-010-01 15 ml in 1 bottle (83299-010-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Salicylic acid 12%

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.
Directions wash the affected area may soak the wart in warm water for 5 minutes dry area thoroughly using the applicator(brush or cotton swab), apply one drop at a time to sufficiently cover each wart allow it to fully absorb and let dry repeat this procedure once or twice daily as needed (until the wart is removed) for up to 12 weeks

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Cnidium monnieri, Podophyllum, Hawthorn, Stellera chamaejasm, Sophora flavescens, Earthy hibiscus bark, Honeysuckle

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.
Use for the removal of common and plantar warts the common wart is easily recognized by the rough "cauliflower-like" appearance of the surface the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern

Purpose

Information about the drug product’s indications for use.
Purpose Wart Remover

Spl product data elements

Usually a list of ingredients in a drug product.
WART REMOVER WART REMOVER CNIDIUM MONNIERI FRUIT STELLERA CHAMAEJASME WHOLE SOPHORA FLAVESCENS ROOT LONICERA CONFUSA WHOLE HAWTHORN LEAF WITH FLOWER ALBIZIA JULIBRISSIN BARK SALICYLIC ACID SALICYLIC ACID PODOPHYLLUM HEXANDRUM ROOT

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.
PRINCIPAL DISPLAY PANEL 01

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask Doctor if discomfort persists. if you have diabetes or poor blood circulation.

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.
Do not use on irritated skin or on any area that is infected or reddened on moles, birthmarks, warts with hair growing from them, warts on the face or mucous membranes

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 Oot Of Reach Of Children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions 1-914-608-1258

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 if discomfort persists. if you have diabetes or poor blood circulation.

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 avoid contact with eyes. If the product gets into the eye, flush with water for 15 minutes avoid inhaling vapors cap the bottle tightly out of direct sunlight and store at room temperature away from heat

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.
Warnings For external use only. Keep away from fire and flame.

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