ANTIPYRINE AND BENZOCAINE
-
antipyrine and
benzocaine solution/ drops
County line Pharmaceuticals, LLC
----------
ANTIPYRINE AND BENZOCAINEOTIC SOLUTION USP
FOR USE IN THE EARS ONLY
Topical Decongestant and Analgesic
Rx Only
DESCRIPTION
Antipyrine and Benzocaine Otic Solution, USP 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:
C11H12N2O MW=188.23
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:
C9H11NO2 MW=165.19
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.
CLINICAL PHARMACOLOGY
Antipyrine and Benzocaine Otic Solution, USP 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, USP does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.
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.
Removal of Cerumen
- facilitates the removal of excessive or impacted cerumen.
CONTRAINDICATIONS
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.
WARNINGS
FOR USE IN EARS ONLY-NOT FOR USE IN EYES
Discontinue promptly if sensitization or irritation occurs.
PRECAUTIONS
Information for Patients
Avoid contaminating the dropper with material from the ear, fingers or other source.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term studies have been conducted.
Pregnancy
Category C
Animal reproduction studies have not been conducted with Antipyrine and Benzocaine Otic Solution, USP. It is also not known whether Antipyrine and Benzocaine Otic Solution, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antipyrine and Benzocaine Otic Solution, USP should be given to a pregnant woman only if clearly needed.
Nursing Mothers
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, USP is administered to a nursing woman.
DOSAGE AND ADMINISTRATION
Acute otitis media
Instill Antipyrine and Benzocaine Otic Solution, USP, 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, USP and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.
Removal of Cerumen
Before
Instill Antipyrine and Benzocaine Otic Solution, USP three times daily for two or three days to help detach cerumen from wall of ear canal and facilitate removal.
After
Antipyrine and Benzocaine Otic Solution, USP is useful for drying out the ear canal or relieving discomfort.
Before and after removal of cerumen, a cotton pledget moistened with Antipyrine and Benzocaine Otic Solution, USP should be inserted into the meatus following instillation.
HOW SUPPLIED
Antipyrine and Benzocaine Otic Solution, USP is supplied in a 15 mL tight light-resistant dropper-bottle with a screwtop bottle cap. Tamper evident seal on bottle cap. Do not use if seal is broken.
15 mL dropper-bottle NDC# 43199-016-15
Storage
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from heat and light. Protect from freezing. Keep tightly closed.
Manufactured for:
County Line Pharmaceuticals, LLC
Brookfield, WI 53005
1-866-207-5636
Rev. 06/09
PRINCIPAL DISPLAY PANEL - 15 mL Carton
NDC# 43199-016-15
Antipyrine and
Benzocaine Otic
Solution USP
Each mL Contains the Active Ingredients:
Antipyrine USP 54 mg
Benzocaine USP 14 mg
Rx Only
county line pharmaceuticals, llc
15 mL (1/2 fl. oz.)
| ANTIPYRINE AND BENZOCAINE
antipyrine and benzocaine solution/ drops |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 11/25/2009 | ||
| Labeler - County line Pharmaceuticals, LLC (015585278) |