Salicylic Acid
Corn And Callus Remover Liquid
Harmon Store Inc.
Human Otc Drug
NDC 63940-021Salicylic Acid also known as Corn And Callus Remover Liquid is a human otc drug labeled by 'Harmon Store Inc.'. National Drug Code (NDC) number for Salicylic Acid is 63940-021. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Salicylic Acid drug includes Salicylic Acid - .17 mg/9.8mL . The currest status of Salicylic Acid drug is Active.
Drug Information:
| Drug NDC: | 63940-021 |
| 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: | Corn And Callus Remover Liquid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Harmon Store Inc. |
| 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 mg/9.8mL
|
| 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: | 24 Sep, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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: | Harmon Store Inc.
|
| 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. |
| 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 |
|---|
| 63940-021-13 | 9.8 mL in 1 BOTTLE, WITH APPLICATOR (63940-021-13) | 24 Sep, 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 corn and callus remover
Product Elements:
Salicylic acid corn and callus remover liquid pyroxylin camphor (natural) castor oil salicylic acid salicylic acid
Indications and Usage:
Uses for the removal of corns and calluses relieves pain by removing corns and calluses
Warnings:
Warnings for external use only. flammable keep away from fire or flame cap bottle tightly and store at room temperature away heat do not use on irritated skin on any area that is infected or reddened if you are a diabetic, or if you have poor blood circulation, except under the advice and supervision of a doctor or podiatrist when using this product avoid contact with eyes avoid inhaling vapors if product gets into the eyes, flush with water for 15 minutes stop and ask a doctor if discomfort persists, see your doctor or podiatrist 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 temperature away heat do not use on irritated skin on any area that is infected or reddened if you are a diabetic, or if you have poor blood circulation, except under the advice and supervision of a doctor or podiatrist when using this product avoid contact with eyes avoid inhaling vapors if product gets into the eyes, flush with water for 15 minutes stop and ask a doctor if discomfort persists, see your doctor or podiatrist 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 avoid inhaling vapors if product gets into the eyes, flush with water for 15 minutes
Dosage and Administration:
Directions wash affected area and dry thoroughly apply one drop at a time with applicator, to sufficiently cover each corn/callus; let dry use cushions with hole centered over corn or callus to relieve pressure (additional cushions may be purchased separately) repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed)
Stop Use:
Stop and ask a doctor if discomfort persists, see your doctor or podiatrist
Package Label Principal Display Panel:
Principal display panel core values liquid corn & callus remover salicylic acid removes corns & calluses safely soft foam cushions and protects 3 cushions 0.33 fl oz (9.8ml) llcr
Further Questions:
Questions? call 1-866-964-0939