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Salicylic acid wart remover - Medication Information

Product NDC Code 51511-596
Drug Name

Salicylic acid wart remover

Type Brand
Active Ingredients
Salicylic acid 40 mg/1
Route TOPICAL
Dosage Form STRIP
RxCUI drug identifier 240559
Application Number M028
Labeler Name ASO Pharmaceutical Co. Ltd.
Packages
Package NDC Code Description
51511-596-01 1 pouch in 1 box (51511-596-01) / 14 strip in 1 pouch
51511-596-10 1 pouch in 1 box (51511-596-10) / 10 strip in 1 pouch
51511-596-12 1200 tray in 1 carton (51511-596-12) / 100 pouch in 1 tray / 14 strip in 1 pouch
51511-596-14 1440 tray in 1 carton (51511-596-14) / 120 pouch in 1 tray / 10 strip in 1 pouch
51511-596-20 2 pouch in 1 box (51511-596-20) / 10 strip in 1 pouch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic acid 40%

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 in warm water for 5 minutes dry area thoroughly remove medicated pad from backing paper by pulling from center of pad apply repeat procedure every 48 hours 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 lanolin, polybutene, rosin ester, rubber

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.
Uses for the removal of common warts. The common wart is easily recognized by the rough "cauliflower-like" appearance of the surface

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.
Salicylic Acid Wart Remover Salicylic Acid LANOLIN NATURAL LATEX RUBBER SALICYLIC ACID SALICYLIC ACID

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 - Carton (Clear) ONE STEP WART REMOVER MAXIMUM STRENGTH EFFECTIVELY REMOVES WARTS Cushions & protects Convenient 1-step bandage Waterproof Clear strips SHAPE OF THE PAD HIFES THE WART Front Panel Clear Wart Remover Principal Display Panel - Carton (Tan) ONE STEP WART REMOVER MAXIMUM STRENGTH EFFECTIVELY REMOVES WARTS Cushions & protects Convenient 1-step bandage Waterproof Tan strips SHAPE OF THE PAD HIFES THE WART Front Panel Tan Wart Remover

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.
Other information store at room temperature avoid excessive heat 99ºF (37ºC) Distributed by: ASO LLC Sarasota, FL 34240 *This product is not manufactured or distributed by Medtech Products, Inc., owners of the registered trademark, Compound W®.

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 on warts on the face or mucous membranes if you are diabetic if you have 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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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 you have discomfort persists

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 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 on warts on the face or mucous membranes if you are diabetic if you have poor blood circulation Stop use and ask a doctor if you have discomfort persists Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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