Label: ANTIPYRINE AND BENZOCAINE- antipyrine and benzocaine solution
- NDC Code(s): 66424-520-35
- Packager: SDA Laboratories
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated November 7, 2013
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- SPL UNCLASSIFIED SECTION
Topical Decongestant and Analgesic
Antipyrine and Benzocaine Otic Solution is an otic solution containing Antipyrine, Benzocaine, Oxyquinoline Sulfate, and Anhydrous Glycerin for use in the ear. The solution congeals at 0°C (32°F), but returns to normal consistency, unchanged, at room temperature.
Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phenyl-3-pyrazolin-5-one. The active ingredient is represented by the structural formula:
Antipyrine occurs as colorless crystals or white powder, has a slightly bitter taste and is soluble in water and alcohol.
Benzocaine is a local anesthetic. It is chemically ethyl p-aminobenzoate or Benzoic acid, 4-amino-, ethyl ester. The active ingredient is represented by the structural formula:
It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents.
EACH mL CONTAINS:
Actives: Antipyrine 54 mg, Benzocaine 14 mg; Inactives: Glycerine (anhydrous), Oxyquinoline Sulfate.Close
- CLINICAL PHARMACOLOGY
Antipyrine and Benzocaine Otic Solution combines the hygroscopic property of anhydrous glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and to alleviate pain and discomfort in acute otitis media.
Antipyrine and Benzocaine Otic Solution does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.Close
- INDICATIONS AND USAGE
Acute Otitis media of various etiologies
- prompt relief of pain and reduction of inflammation in the congestive and serous stages.
- adjuvant therapy during systemic antibiotic administration for resolution of the infection.
Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem, especially in children in whom the tube is shorter, wider, and more horizontal than in adults.
The product is contraindicated in any person with hypersensitivity to any of the components or substances related to them. This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge.Close
FOR USE IN EARS ONLY-NOT FOR USE IN EYES
Discontinue promptly if sensitization or irritation occurs.Close
Information for Patients
Avoid contaminating the dropper with material from the ear, fingers or other source.
Animal reproduction studies have not been conducted with Antipyrine and Benzocaine Otic Solution. It is also not known whether Antipyrine and Benzocaine Otic Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antipyrine and Benzocaine Otic Solution should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Antipyrine and Benzocaine Otic Solution is administered to a nursing woman.
- DOSAGE AND ADMINISTRATION
Acute otitis media
Instill Antipyrine and Benzocaine Otic Solution, permitting the solution to run along the wall of the ear canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Antipyrine and Benzocaine Otic Solution and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.
Removal of Cerumen
Instill Antipyrine and Benzocaine Otic Solution three times daily for two or three days to help detach cerumen from wall of ear canal and facilitate removal.
- HOW SUPPLIED
Antipyrine & Benzocaine Otic Solution is supplied in plastic bottles containing 15 mL (NDC# 66424-520-35).
A tamper evident seal is on the bottle cap. Do not dispense if the seal is broken.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from heat and light. Protect from freezing.
- SPL UNCLASSIFIED SECTION
Greenwich, CT 06830
- PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
Otic Solution, USP
EACH mL CONTAINS
Antipyrine USP 54 mg
Benzocaine USP 14 mg
Inactive ingredients: Glycerine
(anhydrous), Oxyquinoline Sulfate.
FOR USE IN THE EARS ONLY
Tamper evident seal on bottle cap.
Do not use if seal is broken.
15 mL (1/2 fl. oz.)
- INGREDIENTS AND APPEARANCE
ANTIPYRINE AND BENZOCAINE
antipyrine and benzocaine solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66424-520 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Antipyrine (UNII: T3CHA1B51H) (Antipyrine - UNII:T3CHA1B51H) Antipyrine 54 mg in 1 mL Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 14 mg in 1 mL Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Oxyquinoline Sulfate (UNII: 61VUG75Y3P) Product Characteristics Color YELLOW (Slightly) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66424-520-35 15 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/2000 Labeler - SDA Laboratories (948067889) Establishment Name Address ID/FEI Business Operations Sonar Products Inc 104283945 MANUFACTURE(66424-520)