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| Product NDC Code | 42546-279 | ||||
|---|---|---|---|---|---|
| Drug Name | Salicylic acid 6 percent |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SHAMPOO | ||||
| RxCUI drug identifier | 667904 | ||||
| Labeler Name | PruGen LLC | ||||
| Packages |
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Overdosage of Salicylic Acid 6 percent
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.
Drug and or laboratory test interactions
Information about any known interference by the drug with laboratory tests.DRUG INTERACTIONS The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% (w/w) Shampoo 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 Sulfonylureas Hypoglycemia potentiated. Methotrexate Decreases 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. Acidifying Agents Increases plasma salicylate level. Alkanizing Agents Decreased plasma salicylate levels. III.Drugs with complicated interactions with salicylates: DRUG DESCRIPTION OF INTERACTION Heparin Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin treated patients. Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia. Uricosuric Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited. The following alterations of laboratory tests have been reported during salicylate therapy: LABORATORY TESTS EFFECT OF SALICYLATES Thyroid Function Decreased PBI; increased T3 uptake. Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.). 5- Hydroxyindole acetic acid False negative with fluorometric test. Acetone, ketone bodies False positive FeCl3 in Gerhardt reaction; red color persists with boiling .17-OH corticosteroids False reduced values with >4.8g q.d. salicylate. Vanilmandelic acid False reduced values. Uric acid May increase or decrease depending ondose. Prothrombin Decreased levels; slightly increased prothrombin time.
| DRUG | DESCRIPTION OF INTERACTION |
|---|---|
| Sulfonylureas | Hypoglycemia potentiated. |
| Methotrexate | Decreases tubular reabsorption; clinical toxicity from methotrexate can result. |
| Oral Anticoagulants | Increased bleeding. |
| DRUG | DESCRIPTION OF INTERACTION |
|---|---|
| Corticosteroids | Decreases plasma salicylate level; tapering doses of steroids may promote salicylism. |
| Acidifying Agents | Increases plasma salicylate level. |
| Alkanizing Agents | Decreased plasma salicylate levels. |
| DRUG | DESCRIPTION OF INTERACTION |
|---|---|
| Heparin | Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin treated patients. |
| Pyrazinamide | Inhibits pyrazinamide-induced hyperuricemia. |
| Uricosuric | Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited. |
| LABORATORY TESTS | EFFECT OF SALICYLATES |
|---|---|
| Thyroid Function | Decreased PBI; increased T3 uptake. |
| Urinary Sugar | False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.). |
| 5- Hydroxyindole acetic acid | False negative with fluorometric test. |
| Acetone, ketone bodies | False positive FeCl3 in Gerhardt reaction; red color persists with boiling |
| .17-OH corticosteroids | False reduced values with >4.8g q.d. salicylate. |
| Vanilmandelic acid | False reduced values. |
| Uric acid | May increase or decrease depending ondose. |
| 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 effecting qualitative or quantitative changes in the structure of the viable epidermis. The mechanism of action has been attributed to a dissolution of inter cellular cement substance. In a study of the percutaneous absorption of salicylic acid in a 6%salicylic acid gel in four patients with extensive active psoriasis, Taylor and Halprin showed that the 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/100 ml). Peak serum levels occurred within five 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 extra cellular space, patients with a contracted extra cellular space due to dehydration or diuretics have a higher salicylate levels than those with a normal extra cellular space. (See PRECAUTIONS ) The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%). The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate 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. Fifty to eighty percent of a salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the actions of these drugs; by similar competitive 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% (w/w) Shampoo should not be used in any Patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% (w/w) Shampoo 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 SHAMPOO contains 6% w/w salicylic acid USP in a vehicle composed of purified water, disodium laureth sulfosuccinate, cocamidopropyl betaine, hexylene glycol, linoleamidpropyl PG-dimonium chloride phosphate, polyquaternium-22, propylene glycol, sodium C14-16 olefin sulfonate, sodium citrate, sodium lauryl sarcosinate, tetrasodium EDTA, tocopherol acetate and fragrance. Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure: Chemical 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 Wet hair and apply Salicylic Acid 6% (w/w) Shampoo to the scalp. Work into a lather then rinse. Repeat the treatment as needed until the condition clears. Once clearing is apparent, the occasional use of Salicylic Acid 6% (w/w) Shampoo will usually maintain the remission.
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 Dermatologic Use Salicylic Acid 6% (w/w) Shampoo is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). For Podiatric Use Salicylic Acid 6% (w/w) Shampoo is a topical aid in the removal of excessive keratin on the dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.
Spl product data elements
Usually a list of ingredients in a drug product.Salicylic Acid 6 percent Salicylic Acid salicylic acid salicylic acid water CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) SODIUM LAURETH-3 SULFATE TROLAMINE QUATERNIUM-22 COCAMIDOPROPYL BETAINE BEHENTRIMONIUM METHOSULFATE PROPYLPARABEN METHYLPARABEN GLYCERIN EDETATE DISODIUM CHAMOMILE
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 is available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% (w/w) Shampoo. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.
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 - 177 ml Bottle Box NDC 42546-279-06 SALICYLIC ACID 6% (w/w) SHAMPOO Rx Only FOR DERMATOLOGICAL USE ONLY NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE 177 ml PRUGEN ® PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 177 ml Bottle Box
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 DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC,ORAL OR INTRAVAGINAL USE.
Manufactured for: PruGen Pharmaceuticals 18899 N Thompson Peak Pkwy Scottsdale, AZ 85255 Rev 4.0
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 Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salicylic Acid 6% (w/w) Shampoo, 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. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child.
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 six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicylic Acid 6% (w/w) Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).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 six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicylic Acid 6% (w/w) Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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% (w/w) Shampoo is available in 177mL plastic bottles (NDC 42546-279-06). Store at controlled room temperature 20°-25°C (68°-77°F). Do not freeze.
Storage and handling
Information about safe storage and handling of the drug product.Store at controlled room temperature 20°-25°C (68°-77°F). Do not freeze.
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. DRUG INTERACTIONS The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% (w/w) Shampoo 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 Sulfonylureas Hypoglycemia potentiated. Methotrexate Decreases 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. Acidifying Agents Increases plasma salicylate level. Alkanizing Agents Decreased plasma salicylate levels. III.Drugs with complicated interactions with salicylates: DRUG DESCRIPTION OF INTERACTION Heparin Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin treated patients. Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia. Uricosuric Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited. The following alterations of laboratory tests have been reported during salicylate therapy: LABORATORY TESTS EFFECT OF SALICYLATES Thyroid Function Decreased PBI; increased T3 uptake. Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.). 5- Hydroxyindole acetic acid False negative with fluorometric test. Acetone, ketone bodies False positive FeCl3 in Gerhardt reaction; red color persists with boiling .17-OH corticosteroids False reduced values with >4.8g q.d. salicylate. Vanilmandelic acid False reduced values. Uric acid May increase or decrease depending ondose. Prothrombin Decreased levels; slightly increased prothrombin time. 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 six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicylic Acid 6% (w/w) Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salicylic Acid 6% (w/w) Shampoo, 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. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child. Carcinogenesis, Mutagenesis, Impairment of Fertility No data is available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% (w/w) Shampoo. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.
| DRUG | DESCRIPTION OF INTERACTION |
|---|---|
| Sulfonylureas | Hypoglycemia potentiated. |
| Methotrexate | Decreases tubular reabsorption; clinical toxicity from methotrexate can result. |
| Oral Anticoagulants | Increased bleeding. |
| DRUG | DESCRIPTION OF INTERACTION |
|---|---|
| Corticosteroids | Decreases plasma salicylate level; tapering doses of steroids may promote salicylism. |
| Acidifying Agents | Increases plasma salicylate level. |
| Alkanizing Agents | Decreased plasma salicylate levels. |
| DRUG | DESCRIPTION OF INTERACTION |
|---|---|
| Heparin | Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin treated patients. |
| Pyrazinamide | Inhibits pyrazinamide-induced hyperuricemia. |
| Uricosuric | Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited. |
| LABORATORY TESTS | EFFECT OF SALICYLATES |
|---|---|
| Thyroid Function | Decreased PBI; increased T3 uptake. |
| Urinary Sugar | False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.). |
| 5- Hydroxyindole acetic acid | False negative with fluorometric test. |
| Acetone, ketone bodies | False positive FeCl3 in Gerhardt reaction; red color persists with boiling |
| .17-OH corticosteroids | False reduced values with >4.8g q.d. salicylate. |
| Vanilmandelic acid | False reduced values. |
| Uric acid | May increase or decrease depending ondose. |
| Prothrombin | Decreased levels; slightly increased prothrombin time. |
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 Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could resultin salicylism. Excessive application of the product other than is needed to cover the affected area will not result in more therapeutic benefit. 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, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of the Salicylic Acid 6% (w/w) Shampoo should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports and injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin should be replaced by an alternative non-steroidal, anti-inflammatory agent that is not salicylate based. Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and 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