Salicylic Acid
Trifluent Pharma, Llc
Human Prescription Drug
NDC 73352-107Salicylic Acid is a human prescription drug labeled by 'Trifluent Pharma, Llc'. National Drug Code (NDC) number for Salicylic Acid is 73352-107. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Salicylic Acid drug includes Salicylic Acid - 30 mg/g . The currest status of Salicylic Acid drug is Active.
Drug Information:
| Drug NDC: | 73352-107 |
| 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 Prescription 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: | Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Trifluent Pharma, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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 - 30 mg/g
|
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 15 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| 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: | Trifluent Pharma, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312888
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| 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 |
|---|
| 73352-107-30 | 1 TUBE in 1 CARTON (73352-107-30) / 30 g in 1 TUBE | 15 Feb, 2022 | 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. |
Product Elements:
Salicylic acid salicylic acid salicylic acid salicylic acid
Drug Interactions:
Drug interactions it is not known if salicyclic acid with oak bark interacts with other topical medications applied to the treatment area. the use of salicyclic acid with oak bark with other topical drugs has not been studied.
Indications and Usage:
Indications and usage an external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. these conditions include complications associated with pyodermas. indicated also in the treatment of insect bites, burns and fungal infections.
Dosage and Administration:
Dosage and administration patients should be advised to follow these step-by-step instructions for application of salicyclic acid with oak bark ointment: hands should be washed thoroughly. when using tubes, the tip of the tube should not come into contact with the area to be treated; the tube should be recapped tightly after each application. if applying with a cotton-tipped applicator, which is recommended, use once and discard. salicyclic acid with oak bark ointment should be applied twice a day for best results. gently rinse the area to be treated with saline or water and then pat dry. salicyclic acid with oak bark ointment can be applied directly to the wound or placed on dry gauze and then placed on the wound. wet-packs or wet-to-dry dressings are not recommended since they will dilute the ointment and decrease its effectiveness . salicyclic acid with oak bark is designed to provide moisture to the wound. spread a generous quantity of salicyclic acid with oak bark ointment evenly
Read more...over the desired area to yield a thin continuous layer of approximately 1/8 of an inch of thickness. there may be a mild warming sensation or slight burning, to the treated area for 3-5 minutes after application. if irritation occurs or symptoms persist after 10 days, discontinue use and consult your physician. try to keep the area being treated clean and exposed to air when possible. apply an ap- propriate dressing to shield the area from clothes or exposure to water or dirt. if there is no improvement in the wound within 7 days, consult your physician for further evaluation of the wound. if there is no response to the ointment at all, then the wound should be re-evaluated for other contributing factors to the wound healing process.
Contraindications:
Contradictions salicyclic acid with oak bark is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols.
Adverse Reactions:
Adverse reactions salicyclic acid with oak bark is generally well tolerated and non-irritating. a small percentage of patients may experience a temporary burning sensation upon application of the ointment.
Drug Interactions:
Drug interactions it is not known if salicyclic acid with oak bark interacts with other topical medications applied to the treatment area. the use of salicyclic acid with oak bark with other topical drugs has not been studied.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients has not been established.
Description:
Description salicyclic acid with oak bark ointment contains 30 mg salicylic acid per gram in a base containing: benzoic acid, polyethylene glycol 400, polyethylene glycol 3350 and oak bark extract (qrb-7).
Clinical Pharmacology:
Clinical pharmacology the mechanism of action of is salicyclic acid with oak bark is not known. while the following animal data are available, their clinical significance is unknown. it has been demonstrated that salicyclic acid with oak bark significantly reduces methicillin- resistant staphylococcus aureus (mrsa) protected by biofilms in wounds using porcine models. in addition, salicyclic acid with oak bark stimulates reepithelialization of second- degree burns in porcine models.
Clinical Studies:
Clinical studies a randomized, double-blind, placebo-controlled study evaluated the rate of wound re-epithelialization. four partial-thickness wounds (2Ã2 cm & 0.2 mm deep) were created under local anesthesia on the thighs of 13 normal, healthy, male volunteers with an electro keratome. salicyclic acid with oak bark substantially increased the rate of re-ep- ithelialization by 63% over the vehicle alone (p<0.01) and 77% over untreated control (p<0.005).
How Supplied:
How supplied 30 g tube ndc 73352-0107-30 store at 20°c to 25°c (68°f to 77°f), excursions permitted between 15°c and 30°c (between 59°f and 86°f). brief exposure to temperatures up to 40°c (104°f) may be tolerated provided the mean kinetic temperature does not exceed 25°c (77°f); however, such exposure should be minimized.
Package Label Principal Display Panel:
Principal display panel - 30 gram tube label topical ointment ndc 73352-0107-30 salicylic acid 3% with benzoic acid and oak bark extract rx only trifluent pharma net wt. 30 grams principal display panel - 30 gram tube label