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Salicylic Acid Ointment Prescribing Information

Package insert / product label
Dosage form: ointment
Drug classes: Topical acne agents, Topical keratolytics

Medically reviewed by Drugs.com. Last updated on Jan 16, 2024.

Rx Only
Prescribing Information

Salicylic Acid Ointment 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).

Salicylic Acid Ointment - 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 for Salicylic Acid Ointment

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.

Contraindications

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/Side Effects

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.

Salicylic Acid 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 is Salicylic Acid Ointment supplied

30 g tubeNDC 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.

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)*.
MicroorganismQRB-7
MicroorganismParts per Million
*
Data on file: 7 Oaks Pharmaceutical Corp., Easley, SC
Staphylococcus aureus, ATCC 653825,000
Salmonella choleraesuis, ATCC 1070825,000
*Enterococcus faecalis, ATCC 1943350,000
Pseudomonas cepacia, ATCC 108563,125
Staphylococcus epidermidis, ATCC 1791712,500
Alcaligenes faecalis, ATCC 875025,000
Streptococcus uberis ATCC 2795812,500
Escherichia coli, ATCC 2592225,000
Klebsiella pneumoniae, ATCC 1388325,000
Pseudomonas aeruginosa, ATCC 1014525,000
Shigella flexneri type 1A ATCC 919912,500
Pseudomonas paucimobilis, ATCC 298371,563
Streptococcus sanguis, ATCC 1055612,500
Acinetobacter lewoffii, ATCC 995725,000
Pseudomonas putida, HTB Isolate6,250
Aeromonas sobria, ATCC 907125,000
Staphylococcus hominus, ATCC 2784412,500
Staphylococcus haemolyticus, ATCC 2997025,000
Staphylococcus saprophyticus, ATCC 1530525,000
Staphylococcus simulans, ATCC 2784825,000
Micrococcus lylae, ATCC 2756650,000
Streptococcus agalactiae ATCC 1381312,500
Streptococcus equisimilis ATCC 954212,500
Pseudomonas alcaligenes, ATCC 1490925,000
Klebsiella oxytoca, ATCC 1576412,500
Pseudomonas stutzeri, ATCC 1758850,000
Salmonella typhi, ATCC 653912,500
Enterobacter aerogenes, ATCC 1503825,000
Group D enterococcus50,000
Trichophyton mentagraphytes CDC y68+50,000
Rhodoturula rubra HTB Isolate50,000
Enterobacter cloacae, Hosp/Envi isolate25,000
Escherichia coli, Hosp/Envi isolate25,000
Pseudomonas cepacia, Hosp/Envi isolate25,000
Klebsiella pneumoniae, Hosp/Envi isolate25,000
Staphylococcus aureus, Hosp/Envi isolate50,000
Acinetobacter calcoaceticus, ATCC 1796125,000
Alcaligenes faecalis, ATCC 33725,000
Enterobacter cloacae, ATCC 2335525,000
Achromobacter xylosoxidans, HTB Isolate25,000
Salmonella typhi, ATCC 1943025,000
Listeria monocytogenes, ATCC 1531312,500
Serratia marcesans, ATCC 1475625,000
Serratia marcesans, ATCC 1388025,000
Candida albicans, ATCC 1023112,500
Serratia marcensans, Hosp/Envi isolate25,000
Salmonella enteritidis, ATCC 1307625,000
Escherichia coli, ATCC 1122925,000
Proteus mirabilis, ATCC 924025,000

Manufactured for: Trifluent Pharma, LLC • San Antonio, TX
SAL01-02/22

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
SALICYLIC ACID
salicylic acid ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73352-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID30 mg in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73352-107-301 in 1 CARTON02/15/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/15/202207/01/2025
Labeler - Trifluent Pharma LLC (117167281)
Establishment
NameAddressID/FEIBusiness Operations
Dynamic Pharmaceuticals617660712MANUFACTURE(73352-107)

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