Label: SALICYLIC ACID ointment
- NDC Code(s): 73352-107-30
- Packager: Trifluent Pharma LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 10, 2024
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- SPL UNCLASSIFIED SECTION
- DESCRIPTION
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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.
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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
- CONTRADICTIONS
- PRECAUTIONS
- DRUG INTERACTIONS
- ADVERSE REACTIONS
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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
- HOW SUPPLIED
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SPL UNCLASSIFIED SECTION
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. Minimum Inhibitory Concentration Testing of QRB-7 The minimum inhibitory concentrations (MIC) of QRB-7 are listed below in parts per million (PPM)*. Microorganism QRB-7 Microorganism Parts per Million - *
- Data on file: 7 Oaks Pharmaceutical Corp., Easley, SC
Staphylococcus aureus, ATCC 6538 25,000 Salmonella choleraesuis, ATCC 10708 25,000 *Enterococcus faecalis, ATCC 19433 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 - PRINCIPAL DISPLAY PANEL - 30 gram Tube Label
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INGREDIENTS AND APPEARANCE
SALICYLIC ACID
salicylic acid ointmentProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73352-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 30 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73352-107-30 1 in 1 CARTON 02/15/2022 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/15/2022 07/01/2025 Labeler - Trifluent Pharma LLC (117167281) Establishment Name Address ID/FEI Business Operations Dynamic Pharmaceuticals 617660712 MANUFACTURE(73352-107)