FDA Label for Salicylic Acid
View Indications, Usage & Precautions
Salicylic Acid Product Label
The following document was submitted to the FDA by the labeler of this product Trifluent Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Prescribing Information
| Salicylic Acid with Oak Bark inhibited all tested microbial stains, both Gram negative and Gram positive, in a Minimum Inhibitory Concentration (MIC) test against the following 49 select pathogens. |
| Microorganism | QRB-7 |
|---|---|
| Microorganism | Parts per Million |
| Staphylococcus aureus, ATCC 6538 | 25,000 |
| Salmonella choleraesuis, ATCC 10708 | 25,000 |
| 50,000 | |
| Pseudomonas cepacia, ATCC 10856 | 3,125 |
| Staphylococcus epidermidis, ATCC 17917 | 12,500 |
| Alcaligenes faecalis, ATCC 8750 | 25,000 |
| Streptococcus uberis ATCC 27958 | 12,500 |
| Escherichia coli, ATCC 25922 | 25,000 |
| Klebsiella pneumoniae, ATCC 13883 | 25,000 |
| Pseudomonas aeruginosa, ATCC 10145 | 25,000 |
| Shigella flexneri type 1A ATCC 9199 | 12,500 |
| Pseudomonas paucimobilis, ATCC 29837 | 1,563 |
| Streptococcus sanguis, ATCC 10556 | 12,500 |
| Acinetobacter lewoffii, ATCC 9957 | 25,000 |
| Pseudomonas putida, HTB Isolate | 6,250 |
| Aeromonas sobria, ATCC 9071 | 25,000 |
| Staphylococcus hominus, ATCC 27844 | 12,500 |
| Staphylococcus haemolyticus, ATCC 29970 | 25,000 |
| Staphylococcus saprophyticus, ATCC 15305 | 25,000 |
| Staphylococcus simulans, ATCC 27848 | 25,000 |
| Micrococcus lylae, ATCC 27566 | 50,000 |
| Streptococcus agalactiae ATCC 13813 | 12,500 |
| Streptococcus equisimilis ATCC 9542 | 12,500 |
| Pseudomonas alcaligenes, ATCC 14909 | 25,000 |
| Klebsiella oxytoca, ATCC 15764 | 12,500 |
| Pseudomonas stutzeri, ATCC 17588 | 50,000 |
| Salmonella typhi, ATCC 6539 | 12,500 |
| Enterobacter aerogenes, ATCC 15038 | 25,000 |
| Group D enterococcus | 50,000 |
| Trichophyton mentagraphytes CDC y68+ | 50,000 |
| Rhodoturula rubra HTB Isolate | 50,000 |
| Enterobacter cloacae, Hosp/Envi isolate | 25,000 |
| Escherichia coli, Hosp/Envi isolate | 25,000 |
| Pseudomonas cepacia, Hosp/Envi isolate | 25,000 |
| Klebsiella pneumoniae, Hosp/Envi isolate | 25,000 |
| Staphylococcus aureus, Hosp/Envi isolate | 50,000 |
| Acinetobacter calcoaceticus, ATCC 17961 | 25,000 |
| Alcaligenes faecalis, ATCC 337 | 25,000 |
| Enterobacter cloacae, ATCC 23355 | 25,000 |
| Achromobacter xylosoxidans, HTB Isolate | 25,000 |
| Salmonella typhi, ATCC 19430 | 25,000 |
| Listeria monocytogenes, ATCC 15313 | 12,500 |
| Serratia marcesans, ATCC 14756 | 25,000 |
| Serratia marcesans, ATCC 13880 | 25,000 |
| Candida albicans, ATCC 10231 | 12,500 |
| Serratia marcensans, Hosp/Envi isolate | 25,000 |
| Salmonella enteritidis, ATCC 13076 | 25,000 |
| Escherichia coli, ATCC 11229 | 25,000 |
| Proteus mirabilis, ATCC 9240 | 25,000 |
Manufactured for: Trifluent Pharma, LLC • San Antonio, TX
SAL01-02/22
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
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
A randomized, double-blind, placebo-controlled study evaluated the rate of wound re-epithelialization. Four partial-thickness wounds (2×2 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).
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.
Contradictions
Salicyclic acid with oak bark is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols.
Precautions
For external use only. Not to be used in eyes.
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.
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.
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 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.
Pediatric Use
Safety and effectiveness in pediatric patients has not been established.
How Supplied
| 30 g tube | NDC 73352-0107-30 |
Storage And Handling
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.
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
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