Salicylic Acid
Liquid Wart Remover
Dolgencorp, Inc. (dollar General & Rexall)
Human Otc Drug
NDC 55910-404Salicylic Acid also known as Liquid Wart Remover is a human otc drug labeled by 'Dolgencorp, Inc. (dollar General & Rexall)'. National Drug Code (NDC) number for Salicylic Acid is 55910-404. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Salicylic Acid drug includes Salicylic Acid - .17 g/9mL . The currest status of Salicylic Acid drug is Active.
Drug Information:
| Drug NDC: | 55910-404 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Salicylic Acid |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Liquid Wart Remover |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dolgencorp, Inc. (dollar General & Rexall) |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SALICYLIC ACID - .17 g/9mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 29 Jun, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part358F |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0034197013246
|
| UPC stands for Universal Product Code. |
| UNII: | O414PZ4LPZ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 55910-404-31 | 9 mL in 1 BOTTLE, WITH APPLICATOR (55910-404-31) | 29 Jun, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose wart remover
Product Elements:
Salicylic acid liquid wart remover pyroxylin camphor (natural) castor oil salicylic acid salicylic acid
Indications and Usage:
Uses for the removal of common and plantar warts. the common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. plantar wart is recognized by the location only on the bottom of the foot, its tenderness and the interruption of the footprint pattern.
Warnings:
Warnings for external use only. flammable keep away from fire or flame cap bottle tightly and store at room temerature away from heat do not use if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist on genital warts and warts on the face on moles, birthmarks and warts with hair growing from them on mucous membranes on irritated, infected or reddened skin when using this product avoid contact with eyes. if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors stop use and ask doctor if discomfort persists. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only. flammable keep away from fire or flame cap bottle tightly and store at room temerature away from heat do not use if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist on genital warts and warts on the face on moles, birthmarks and warts with hair growing from them on mucous membranes on irritated, infected or reddened skin when using this product avoid contact with eyes. if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors stop use and ask doctor if discomfort persists. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with eyes. if product gets into the eyes, flush with water for 15 minutes avoid inhaling vapors
Dosage and Administration:
Directions wash affected area, may soak wart in warm water for 5 minutes dry area thoroughly apply small amount of wart remover with applicator to sufficiently cover each wart let dry and repeat this procedure once or twice daily until wart is removed for up to 12 weeks
Stop Use:
Stop use and ask doctor if discomfort persists.
Package Label Principal Display Panel:
Principal display panel rexall miximum strength wart remover liquid with salicylic acid 17% removes common and plantar warts conventient applicator safe and effective net 0.31 fl. oz. (9 ml) dollar general - rexall - liquid wart remover
Further Questions:
Questions? call 1-866-964-0939