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| Product NDC Code | 54295-304 | ||||
|---|---|---|---|---|---|
| Drug Name | Salicylic acid |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1095689 | ||||
| Labeler Name | Trinity Pharmaceuticals, LLC | ||||
| Packages |
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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 A localized irritant reaction may occur if Salicylic Acid, 27.5% is applied to the normal skin surrounding the wart. Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Although the exact mode of action for salicylic acid in the treatment of warts is unknown, its activity appears to be associated with its keratolytic action, which results in mechanical removal of epidermal cells infected with wart viruses.
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, 27.5% should not be used by diabetics or patients with impaired blood circulation. Salicylic Acid, 27.5% should not be used on moles, birthmarks, unusual warts with hair growing from them or warts on the face.
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, 27.5% is a topical preparation containing 27.5% Salicylic Acid in a film-forming vehicle composed of: acrylates copolymer, isopropyl alcohol, isobutyrate, n-butyl acetate, and polyvinyl butyrate. The pharmacologic activity of this medication is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a film-forming vehicle designed to cover the wart without the need for a bandage. The chemical structural formula of salicylic acid is: 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 Prior to application of Salicylic Acid, 27.5% soak wart in warm water for five minutes. Remove any loosened tissue by gently rubbing with a brush, wash cloth, emery board or pumice stone. Dry thoroughly. Using the brush applicator supplied, apply twice to entire wart surface, allowing the first application to dry before applying the second. Treatment should be once or twice a day and should continue as directed by physician. Be careful not to apply to surrounding skin. Clinically visible improvement will normally occur during the first or second week of therapy. Maximum resolution may be expected after four to six weeks of drug use.
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 USES Salicylic Acid, 27.5% is indicated for the topical treatment and removal of common warts and plantar warts.
Spl product data elements
Usually a list of ingredients in a drug product.Salicylic Acid salicylic acid ISOPROPYL ALCOHOL BUTYL ACETATE SALICYLIC ACID SALICYLIC ACID
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.Salicylic Acid, 27.5% 10 mL Container Label Principal Display Panel Text: NDC 54295-304-11 Rx only For topical use only Not for ophthalmic use Salicylic Acid, 27.5% 10 mL Salicylic Acid, 27.5% carton 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.KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Marketed By: Trinity Pharmaceuticals LLC 1 International Plaza, Suite 550 Philadelphia, PA 19113 TrinityPharmaLLC.com REV 11/13
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Rx only FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. DESCRIPTION Salicylic Acid, 27.5% is a topical preparation containing 27.5% Salicylic Acid in a film-forming vehicle composed of: acrylates copolymer, isopropyl alcohol, isobutyrate, n-butyl acetate, and polyvinyl butyrate. The pharmacologic activity of this medication is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a film-forming vehicle designed to cover the wart without the need for a bandage. The chemical structural formula of salicylic acid is: chemical structure CLINICAL PHARMACOLOGY Although the exact mode of action for salicylic acid in the treatment of warts is unknown, its activity appears to be associated with its keratolytic action, which results in mechanical removal of epidermal cells infected with wart viruses. INDICATIONS AND USES Salicylic Acid, 27.5% is indicated for the topical treatment and removal of common warts and plantar warts. CONTRAINDICATIONS Salicylic Acid, 27.5% should not be used by diabetics or patients with impaired blood circulation. Salicylic Acid, 27.5% should not be used on moles, birthmarks, unusual warts with hair growing from them or warts on the face. PRECAUTIONS Salicylic Acid, 27.5% is for external use only. Do not permit Salicylic Acid, 27.5% to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Salicylic Acid, 27.5% should not be allowed to contact normal skin surrounding the wart. Treatment should be discontinued if excessive irritation occurs. Salicylic Acid, 27.5% is flammable and should be kept away from fire or flame. Keep bottle tightly capped when not in use. ADVERSE REACTIONS A localized irritant reaction may occur if Salicylic Acid, 27.5% is applied to the normal skin surrounding the wart. Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed. DOSAGE AND ADMINISTRATION Prior to application of Salicylic Acid, 27.5% soak wart in warm water for five minutes. Remove any loosened tissue by gently rubbing with a brush, wash cloth, emery board or pumice stone. Dry thoroughly. Using the brush applicator supplied, apply twice to entire wart surface, allowing the first application to dry before applying the second. Treatment should be once or twice a day and should continue as directed by physician. Be careful not to apply to surrounding skin. Clinically visible improvement will normally occur during the first or second week of therapy. Maximum resolution may be expected after four to six weeks of drug use. HOW SUPPLIED Salicylic Acid, 27.5% is supplied in 10 mL amber glass bottles with brush applicator - NDC 54295-304-11. Store at 20ºC to 25ºC (68ºF to 77ºF)., excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized. Protect from freezing.
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, 27.5% is supplied in 10 mL amber glass bottles with brush applicator - NDC 54295-304-11. Store at 20ºC to 25ºC (68ºF to 77ºF)., excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized. Protect from freezing.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Salicylic Acid, 27.5% is for external use only. Do not permit Salicylic Acid, 27.5% to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Salicylic Acid, 27.5% should not be allowed to contact normal skin surrounding the wart. Treatment should be discontinued if excessive irritation occurs. Salicylic Acid, 27.5% is flammable and should be kept away from fire or flame. Keep bottle tightly capped when not in use.
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