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| Product NDC Code | 42192-134 | ||||
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| Drug Name | Salicylic acid |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 312893 | ||||
| Labeler Name | Acella Pharmaceuticals, LLC | ||||
| Packages |
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Overdosage of SALICYLIC ACID
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE See WARNINGS
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Excessive erythema and scaling conceivably could result from use on open skin lesions.
SALICYLIC ACID Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions. (The following interactions are from a published review 5 and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% Gel is not known.) I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: Drug Description of Interaction Tolbutamide; Sulfonylureas Hypoglycemia potentiated Methotrexate Decrease tubular reabsorption; clinical toxicity from methotrexate can result Oral Anticoagulants Increased bleeding II. Drugs changing salicylate levels by altering renal tubular reabsorption: Drug Description of Interaction Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism Ammonium Sulfate Increases plasma salicylate level III. Drugs with complicated interactions with salicylates: Drug Description of Interaction Heparin Salicylate decreases platelet adhesivesness and interferes with hemostasis in heparin-treated patients Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia Uricosuric Agents Effect of probenecid, sulfinpyrazone and phenylbutazone inhibited The following alterations of laboratory tests have been reported during salicylate therapy 6 : Laboratory Tests Effect of Salicylates Thyroid Function Decreased PBI; increased T 3 uptake Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2 - 5 g qd) 5 Hydroxyindole Acetic Acid False negative with fluorometric test Acetone, Ketone Bodies False positive FeCl 3 in Gerhardt reaction; red color persists with boiling 17-OH Corticosteroids False reduced values with >4.8 g qd salicylate Vanilmandelic Acid False reduced values Uric Acid May increase or decrease depending on dose Prothrombin Decreased levels; slightly increased prothrombin time
| I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: | ||
| Drug | Description of Interaction | |
|---|---|---|
| Tolbutamide; Sulfonylureas | Hypoglycemia potentiated | |
| Methotrexate | Decrease tubular reabsorption; clinical toxicity from methotrexate can result | |
| Oral Anticoagulants | Increased bleeding | |
| II. Drugs changing salicylate levels by altering renal tubular reabsorption: | ||
| Drug | Description of Interaction | |
| Corticosteroids | Decreases plasma salicylate level; tapering doses of steroids may promote salicylism | |
| Ammonium Sulfate | Increases plasma salicylate level | |
| III. Drugs with complicated interactions with salicylates: | ||
| Drug | Description of Interaction | |
| Heparin | Salicylate decreases platelet adhesivesness and interferes with hemostasis in heparin-treated patients | |
| Pyrazinamide | Inhibits pyrazinamide-induced hyperuricemia | |
| Uricosuric Agents | Effect of probenecid, sulfinpyrazone and phenylbutazone inhibited | |
| The following alterations of laboratory tests have been reported during salicylate therapy 6: | ||
| Laboratory Tests | Effect of Salicylates | |
| Thyroid Function | Decreased PBI; increased T 3 uptake | |
| Urinary Sugar | False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2 - 5 g qd) | |
| 5 Hydroxyindole Acetic Acid | False negative with fluorometric test | |
| Acetone, Ketone Bodies | False positive FeCl 3 in Gerhardt reaction; red color persists with boiling | |
| 17-OH Corticosteroids | False reduced values with >4.8 g qd salicylate | |
| Vanilmandelic Acid | False reduced values | |
| Uric Acid | May increase or decrease depending on dose | |
| Prothrombin | Decreased levels; slightly increased prothrombin time | |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in structure of the viable epidermis. 1,2 The mechanism of action has been attributed to dissolution of intercellular cement substance. 3 In a study of the percutaneous absorption of salicylic acid from Salicylic Acid 6% Gel in four patients with extensive active psoriasis, Taylor and Halprin 4 showed that peak serum salicylate levels never exceeded 5 mg/100 mL even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100mL). Peak serum levels occurred within 5 hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space. 5 (See PRECAUTIONS ). The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%). 4 The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space. 5 Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs. By similar competetive mechanisms other drugs can influence the serum levels of salicylate. (See PRECAUTIONS ).
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Salicylic Acid 6% Gel should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% Gel should not be used in children under 2 years of age.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Salicylic Acid 6% Gel is applied topically and used in the removal of excessive keratin in hyperkeratotic skin disorders. Each gram of Salicylic Acid 6% Gel contains salicylic acid 6% as the active ingredient, and the following inactive ingredients: hydroxypropylcellulose and propylene glycol. CHEMICAL STRUCTURE Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following chemical structure: STRUCTURE
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION The preferable method of use is to apply Salicylic Acid 6% Gel thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salicylic Acid 6% Gel will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. Unless hands are being treated, hands should be rinsed thoroughly after application.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with psoriasis or thickened skin of palms and soles, corns and calluses.
Spl product data elements
Usually a list of ingredients in a drug product.Salicylic Acid SALICYLIC ACID PROPYLENE GLYCOL HYDROXYPROPYL CELLULOSE (1600000 WAMW) SALICYLIC ACID SALICYLIC ACID
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility - No data are available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% Gel. It has been shown to lack mutagenic potential in the Ames Salmonella test. KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 40 g container label NDC 42192-134-40 Salicylic Acid 6% GEL Rx only Net Wt. 40 g Acella PHARMACEUTICALS, LLC primary-label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx Only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. NOTE: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein. MANUFACTURED FOR Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 L-0079 Rev 1020-02
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.REFERENCES: Davies M, Marks R: Br J Dermatol 95: 187-192, 1976. Mars R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975. Huber C, Christophers E: Arch Derm Res 257: 293-297, 1977. Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975. Goldsmith LA: Int J Dermatol 18: 32-36. Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers - It is not known whether topically applied salicylic acid is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering Salicylic Acid 6% Gel to nursing mothers and nursing mothers should certainly not apply Salicylic Acid 6% Gel to the chest area or any other part of the body with which the nursing child’s mouth is likely to come in contact. Because of the potential for serious advers reactions in nursing infants from the mother’s use of Salicylic Acid 6% Gel, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy (Category C) - Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent 4 times the maximum daily human dose of salicylic acid (as supplied in one tube, 40 g of Salicylic Acid 6% Gel) when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicylic Acid 6% Gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Nursing Mothers - It is not known whether topically applied salicylic acid is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering Salicylic Acid 6% Gel to nursing mothers and nursing mothers should certainly not apply Salicylic Acid 6% Gel to the chest area or any other part of the body with which the nursing child’s mouth is likely to come in contact. Because of the potential for serious advers reactions in nursing infants from the mother’s use of Salicylic Acid 6% Gel, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Salicylic Acid 6% Gel is supplied in a 40 gram plastic tube bearing the NDC Number 42192-134-40.
Storage and handling
Information about safe storage and handling of the drug product.Store at controlled room temperature 15° - 30°C (59° - 86°F). [See USP “Controlled Room Temperature”]
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS For external use only. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. Peeling of the skin may increase as the salicylic acid works to loosen excess keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician. Flammable. Keep away from heat and open flame. Keep this and all medications out of the reach of children .
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS Contact with eyes, lips, broken or inflamed skin, and all mucous membranes should be avoided. Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of Salicylic Acid 6% Gel should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential of developing Reye’s syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API