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Compound w - Medication Information

Product NDC Code 63029-595
Drug Name

Compound w

Type Brand
Active Ingredients
Salicylic acid 170 mg/g
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 210140,
312880
Application Number M028
Labeler Name Medtech Products Inc.
Packages
Package NDC Code Description
63029-595-12 1 tube in 1 carton (63029-595-12) / 7 g in 1 tube
63029-595-14 1 bottle in 1 carton (63029-595-14) / 7 g in 1 bottle
63029-595-25 1 tube in 1 carton (63029-595-25) / 7 g in 1 tube
63029-595-30 1 tube in 1 carton (63029-595-30) / 7 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic acid 17% w/w

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 affected area may soak wart in warm water for 5 minutes dry area thoroughly by squeezing tube gently, apply one drop at a time to sufficiently cover each wart let dry repeat this procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients alcohol, camphor, castor oil, ethyl acetate, hydroxypropyl cellulose, hypophosphorous acid, isopropanol, nitrocellulose, polysorbate 80, water

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 on 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.
Compound W salicylic acid SALICYLIC ACID SALICYLIC ACID ALCOHOL CAMPHOR (NATURAL) CASTOR OIL ETHYL ACETATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPOPHOSPHOROUS ACID ISOPROPYL ALCOHOL PYROXYLIN POLYSORBATE 80 WATER

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 Compound W WART REMOVER SYSTEM MAXIMUM STRENGTH FAST ACTING GEL + CONSEAL Salicylic acid NET WT 0.25 OZ (7g) PRINCIPAL DISPLAY PANEL Compound W WART REMOVER SYSTEM MAXIMUM STRENGTH FAST ACTING GEL + CONSEAL Salicylic acid NET WT 0.25 OZ (7g) PRINCIPAL DISPLAY PANEL Compound W Total Care Wart & Skin Salicylic acid – Wart Remover GEL NET WT 0.25 OZ (7g) Compound W Total Care Wart & Skin Salicylic acid – Wart Remover GEL NET WT 0.25 OZ (7g) PRINCIPAL DISPLAY PANEL Compound W Wart Remover Salicylic acid MAXIMUM STRENGTH GEL NET WT 0.25 OZ (7g) Compound W Wart Remover Salicylic acid MAXIMUM STRENGTH FAST ACTING GEL NET WT 0.25 OZ (7g) PRINCIPAL DISPLAY PANEL Compound W Wart Remover Gel + Shield Gel Net Wt 0.25 oz (7g) I 12 proshield patches Compound W Wart Remover Gel + Shield Gel Net Wt 0.25 oz (7g) I 12 proshield patches

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.
Compound W ® Salicylic Acid Wart Remover MAXIMUM STRENGTH FAST ACTING GEL NET WT 0.25 OZ (7 g) Drug Facts

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, genital warts or warts on the face or mucous membranes if you have diabetes or poor blood circulation

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

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information store at room temperature avoid excessive heat 37°C (99°F) skin discoloration may occur during or after use wipe the tip of the tube with a paper towel between uses

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-443-4908 CompoundW.com

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 ask a doctor if discomfort persists.

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 this product avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes. avoid inhaling vapors cap tightly 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. Flammable. Keep away from fire and flame. Do not use on irritated skin or on any area that is infected or reddened on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes if you have diabetes or poor blood circulation When using this product avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes. avoid inhaling vapors cap tightly and store at room temperature away from heat Stop use and ask a doctor if discomfort persists. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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