NDC 42783-324 28.5% Salicylic Acid

Product Information

28.5% Salicylic Acid is product labeled by Elorac, Inc.. The product's dosage form is and is administered via form.

Product Code42783-324
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		28.5% Salicylic Acid
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Elorac, Inc.
Labeler Code42783
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		04-30-2018
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2019
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		I
NDC Code Structure

What are the uses for 28.5% Salicylic Acid?


Product Packages

NDC 42783-324-10

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 10 mL in 1 BOTTLE, WITH APPLICATOR

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

28.5% Salicylic Acid Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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28.5% Salicylic Acid Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Rx only

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.


Description



This Product is a topical preparation containing 28.5% salicylic acid extended release in a proprietary film-forming virucidal solution composed of acrylates copolymer, butyl acetate, carthamus tinctorius seed oil, cocamidopropyl dimethylamine, ethylhexylglycerin, isopropyl alcohol, isopropyl-metacresol, olea europaea fruit oil, phenic acid, phenoxyethanol, polysorbate 80, polyvinyl butyral, trimethyl pentanyl diisobutyrate, and water. The pharmacologic activity of the Product is generally attributed to the keratolytic activity of salicylic acid, which is incorporated into a polyacrylic, film-forming virucidal solution designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is:

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5-01.jpg - 5 01


Clinical Pharmacology



Although the exact mode of action for salicylic acid in the treatment of warts is unknown, its activity appears to be associated with its keratolytic action, which results in mechanical removal of epidermal cells infected with wart viruses. This Product incorporates a unique patented extended release form of salicylic acid that provides for enhanced release of salicylic acid for over 24 hours.

The virucidal complex incorporated into this Products proprietary solution is designed to help reduce risk of reinfection at the wart site, as well as prevent viral contamination of the product under normal usage.


Indications And Usage



This Product is indicated for the topical treatment and removal of common warts and plantar warts.


Contraindications



Patients with diabetes or impaired blood circulation should not use the Product. This Product also should not be used on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.


Precautions



This Product is for external use only. Do not permit it to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. The Product should not be allowed to contact normal skin surrounding the wart site, since localized irritation may occur. Treatment should be discontinued if excessive irritation occurs.

The Product is flammable. Keep away from fire or flame. Keep bottle tightly capped when not in use.


Adverse Reactions



A localized irritant reaction may occur if this Product is applied to the normal skin surrounding the wart. Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.


Dosage And Administration



Prior to applying the Product, soak wart in warm water for five minutes. Remove any loose tissue by gently rubbing with a washcloth, emery board, or pumice stone. Dry the wart site thoroughly. Using the brush applicator supplied, apply it twice to the entire wart surface, allowing the first application to dry before applying the second. Continue treatment once or twice a day as directed by your healthcare provider. Be careful not to apply to surrounding skin.

Clinically visible improvement normally occurs during the first or second week of therapy. Resolution may be expected after four to six weeks of the Product use, though some warts may take longer to remove.


How Supplied



This Product is supplied in 10 mL amber bottles with a brush applicator (NDC 42783-324-10).

Store at 15° to 30°C (59° to 86°F).

Manufactured for:

Elorac, Inc.

Vernon Hills, IL 60061

U.S. Patent No. 6,979,440

Additional Patent Pending

© 2014 Elorac, Inc.

1/2018

211909


Patient Instructions



Your health care provider has prescribed this Product, a topical prescription preparation for the treatment of common warts and plantar warts. In order for it to work properly and to ensure maximum benefit, the following instructions should be followed carefully. Of course, as with any medication, always consult your health care provider if you experience any discomfort or unexpected reactions.

STEP 1

WASH

  • Soak wart area in warm water for about 5 minutes.
  • Remove any loose tissue using a washcloth, emery board, or pumice stone.
  • Dry thoroughly.

    • 5-04.jpg - 5 04

    5-04.jpg - 5 04

    STEP 2

    BRUSH

    • Using the brush applicator supplied, apply twice to entire wart surface, allowing the first application to dry before applying the second.
    • Be careful not to apply to surrounding skin.
    • Leave the Product on wart area after it dries.

      • Repeat Step 1 and Step 2 once or twice daily as advised by the health care provider.

      Clinically visible improvement will normally occur during the first or second week of therapy. Resolution may be expected after four to six weeks of the Product use, though some warts may take longer to remove.

      Vernon Hills, IL 60061


28.5% Salicylic Acid Extended Release Antiviral Film-Forming Solution:  Container Label Principal Display Panel



NDC 42783-324-10

28.5% Salicylic Acid Extended Release Antiviral Film-Forming Solution

1/3 fl. oz. (10 mL)

Rx only

bottle-label.jpg - bottle label

bottle-label.jpg - bottle label


28.5% Salicylic Acid Extended Release Antiviral Film-Forming Solution: Carton Label Principal Display Panel



NDC 42783-324-10

28.5% Salicylic Acid Extended Release Antiviral Film-Forming Solution

1/3 fl. oz. (10 mL)

Rx only

carton-label.jpg - carton label

carton-label.jpg - carton label


* Please review the disclaimer below.